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PURPOSE To determine volume fill levels, estimated costs, and force expulsion requirements per bottle of topical ophthalmic steroids commonly used in the United States. SETTING Tertiary care academic referral center. DESIGN Prospective laboratory investigation. METHODS Eight commercially available medications were tested: loteprednol 0.5%, loteprednol gel 0.5%, loteprednol gel 0.38%, difluprednate 0.05%, generic fluorometholone 0.1%, branded fluorometholone 0.1%, generic prednisolone 1.0%, and branded prednisolone 1.0%. Ten bottles of each medication were tested. A double-blinded method was used to measure actual bottle-fill volume and number of drops dispensed per bottle. The total perioperative cost per drop was calculated for each medication using average cash price. Force requirements were measured using a customized force gauge apparatus. Formulations were compared using Kruskal-Wallis one-way ANOVAs. RESULTS All formulations were able to cover postoperative periods commensurate with commonly used dosing regimens for cataract surgery. All medications had greater than sticker volume. Loteprednol 0.5% suspension and branded fluorometholone had the highest and lowest number of drops among the medications tested, respectively. Loteprednol 0.38% gel was the most expensive medication, while generic prednisolone 1.0% was the least expensive. Gel and branded formulations of ophthalmic steroids required less expulsion force compared to other tested formulations. CONCLUSIONS Volume fill levels, patient-incurred costs and expulsion force requirements per bottle of topical steroid medications vary widely. Clinicians may wish to consider these findings when determining their perioperative prescribing regimens.

Use of a combination corticosteroid and antibiotic in a single formulation is common in the treatment of ocular inflammatory conditions for which corticosteroid therapy is indicated and there exists a risk of superficial bacterial infection. Loteprednol etabonate (LE) is a corticosteroid engineered to maintain potent anti-inflammatory activity while minimizing the risk of undesirable class effects of corticosteroids, such as elevated intraocular pressure and cataract. Tobramycin is a broad-spectrum aminoglycoside antibiotic that is considered generally safe and well tolerated. An ophthalmic suspension combining LE 0.5% and tobramycin 0.3% (LE/T) is approved in the US and several other countries. Use of a combination therapy increases convenience, which may promote patient adherence. A systematic literature review was conducted to examine the efficacy and safety of LE/T for ocular inflammatory conditions within the scope of its labeled indications. Results of published studies indicate that LE/T is effective in the treatment of blepharokeratoconjunctivitis in adults, with similar efficacy as dexamethasone 0.1%/tobramycin 0.3%, but is associated with a lower risk of clinically significant increases in intraocular pressure as demonstrated in both efficacy and safety studies and studies with healthy volunteers. Furthermore, studies in children with blepharitis or blepharoconjunctivitis indicate LE/T was well tolerated in this population, although efficacy vs vehicle was not demonstrated, potentially due to improvements in all groups overall and/or limited sample size. Separately, tobramycin demonstrated potent in vitro activity against most bacterial species associated with blepharitis. In conclusion, published data demonstrate the utility of LE/T for the treatment of the various clinical manifestations of blepharokeratoconjunctivitis in adults.

Background To evaluate the effects of pretreatment for dry eye disease (DED) on the accuracy of intraocular lens (IOL) power calculation. Methods Patients who underwent uneventful cataract surgery were included in the study. IOL power was determined using the SRK/T and Barrett Universal II (Barrett) formulas. The patients were divided into non-pretreatment and pretreatment groups, and those in the pretreatment group were treated with topical 0.5% loteprednol etabonate and 0.05% cyclosporin A for 2 weeks prior to cataract surgery. Ocular biometry was performed in all groups within 2 days before surgery. The mean prediction error, mean absolute error (MAE), and proportions of refractive surprise were compared between the non-pretreatment and pretreatment groups at 1 month postoperatively. Refractive surprise was defined as MAE ≥ 0.75D. Results In a total of 105 patients, 52 (52 eyes) were in the non-pretreatment group and 53 (53 eyes) in the pretreatment group. The MAE was 0.42 ± 0.33, 0.38 ± 0.34 (SRK/T, Barrett) and 0.23 ± 0.19, 0.24 ± 0.19 in the non-pretreatment and pretreatment groups, respectively (p p = 0.024/0.016]. Pretreatment of DED was related to a reduction in postoperative refractive surprise. [SRK/T/Barrett: OR = 0.18/0.17 (95% CI: 0.05–0.71/0.05–0.60), p = 0.014/0.006]. Conclusions The accuracy of IOL power prediction can be increased by actively treating DED prior to cataract surgery.

BACKGROUND: Vernal keratoconjunctivitis is a chronic, seasonally exacerbated, allergic inflammation of the eye. The study aims to evaluate the efficacy and safety of oral montelukast in treating vernal keratoconjunctivitis in pediatric patients. METHODS: This is a 26-week, prospective, randomized, open-label study. Fifty-eight patients were randomly assigned to two groups—the treatment (montelukast) and control groups. At the beginning of the study, both the groups received topical loteprednol etabonate (0.1%) in tapering doses for a month, and topical olopatadine (0.1%) for the first 3 months. Symptoms and signs observed before and after treatment and assigned scores were studied. The primary efficacy endpoint was change in the mean score on the visual analog scale (VAS) for each subjective symptom. The secondary efficacy endpoint was change in the total score of objective signs. RESULTS: The montelukast group showed clinically relevant improvements in the signs and symptoms of vernal keratoconjunctivitis, compared to the control group. There was considerable improvement in clinical signs. Individual symptoms such as redness, itching, foreign body sensation, and tearing showed significant improvement at 6 months follow-up. The gradual improvement in symptoms until the last visit was statistically more significant within montelukast group. Mean VAS score showed statistically significant improvement in itching (p

We report two patients who developed toxic keratopathy following high-dose cytarabine chemotherapy and whose symptoms resolved following topical loteprednol etabonate 0.5% treatment. A 25-year-old woman and a 26-year-old man with acute myeloid leukemia were referred to our department with symptoms of ocular discomfort, photophobia, and blurred vision after consolidation chemotherapy. Central corneal epithelial microcysts were observed bilaterally in both patients, and in vivo confocal microscopy showed highly reflective disseminated granular and irregular intraepithelial opacities, mainly in the basal epithelial layers. Loteprednol etabonate 0.5% relieved both patients' symptoms in less than a week, and the microcysts disappeared in 2 to 3 weeks of treatment. Although there is no standardized treatment protocol for cytarabine-induced corneal toxicity, dexamethasone 0.1% and prednisolone phosphate 1.0% were reported to be effective in the resolution of discomfort and symptoms. In the two patients we report herein, loteprednol etabonate 0.5% four times daily was also effective in suppressing the symptoms.

Dry eye disease (DED) is a common ocular condition that can impair vision and may adversely impact quality of life. Due to the inflammatory nature of this disorder, topical corticosteroids are an effective treatment option, particularly for moderate-to-severe DED when first-line treatments, such as ocular lubricants, are insufficient. Loteprednol etabonate (LE) is a retrometabolically designed corticosteroid with a low propensity to cause corticosteroid-related adverse effects, such as elevated intraocular pressure (IOP). This review was conducted to provide an assessment of published studies on the use of LE for treatment of inflammation associated with DED. Twelve prospective and 2 retrospective studies evaluating LE ophthalmic suspension 0.5% and 2 prospective studies evaluating LE ophthalmic gel 0.5% were identified. LE given as monotherapy or with artificial tears (AT) improved signs of DED, especially among patients with a more pronounced inflammatory component, and also improved DED symptoms compared to baseline and/or control. Treatment with LE before cyclosporine A (CsA) therapy reduced stinging upon CsA initiation and provided more rapid relief of DED signs and symptoms than CsA plus AT alone. In patients with meibomian gland dysfunction, LE alone, or in addition to eyelid scrubs/warm compresses, reduced clinical signs and symptoms, and tear proinflammatory cytokine levels. Overall, LE was safe and well tolerated, with minimal effects on IOP. While larger and longer-term studies are warranted, these data support the use of LE as a safe and effective treatment option for DED.

Supplemental Digital Content is Available in the Text., Purpose: To identify risk factors for the development of ocular hypertension after keratoplasty. Methods: A systematic search in PubMed and Embase identified 67 relevant articles published between January 1990 and 2019. We preferentially searched for data on an intraocular pressure increase above 21 mmHg at 6 months or a threshold or time point close to that and reported whether the preoperative or intraoperative status of risk factors was defined. The results were presented in evidence tables, visualizing the direction of the association, whether univariate and/or multivariate analysis was performed, and the significance level (P < 0.05). Four researchers, blinded for the risk factors, independently assigned a level of evidence (definitely, probably, possibly, not associated). Consensus was met during group meetings. Results: From the 110 studied risk factors, pre-existing glaucoma, high preoperative IOP and combined keratoplasty with removal or exchange of an intraocular lens (IOL) were definitely associated with an increased risk. In addition, if the pre-or postoperative lens status was undefined, aphakia and pseudophakia with the IOL in the anterior or posterior chamber were also definitely associated with an increased risk when compared to phakia. Glaucoma in the contralateral eye, indication of bullous keratopathy, African American descent, preoperative treatment with cyclosporine or olopatadine 0.1%, postoperative treatment with prednisolone acetate 1%, and combined surgery in general (ie, the type of surgeries undefined in primary studies) were probably associated. Multiple other identified risk factors lack sufficient evidence and need additional investigation. Conclusions: Risk factors with a definite association can help clinicians select patients at risk and adjust their follow-up and treatment. The other factors need further investigation.

Pain and inflammation are common experiences following ocular surgery and, if uncontrolled, can compromise patients’ vision, functioning and quality of life. Corticosteroid drugs are available to manage inflammation and discomfort but have limitations in penetrating the ocular mucus barrier to reach the target ocular tissues. KPI-121 1% (INVELTYS®) is a novel formulation of loteprednol etabonate that employs innovative proprietary technology to deliver nanoparticle-sized mucus-penetrating particles to the cornea. Results from clinical trials demonstrate that KPI-121 1% is effective and well tolerated. KPI-121 1% uses mucopenetrative technology for ophthalmic use and is the only US FDA-approved twice-daily ocular corticosteroid indicated for the treatment of inflammation and pain after ocular surgery.

Background To compare the effect of loteprednol suspension eye drops after corneal transplantation with the effect of prednisolone acetate eye drops. Methods A total of 234 patients (234 eyes) who underwent penetrating keratoplasty (PKP) and lamellar keratoplasty (LKP) were retrospectively included. Patients who received 1 % prednisolone acetate eye drops were defined as 1 % prednisolone acetate eye drop group (n = 96), and patients who received 0.5 % loteprednol suspension eye drops were defined as 0.5 % loteprednol suspension eye drop group (n = 138). Results 35 cases in 1 % prednisolone acetate eye drops group and 27 cases in 0.5 % loteprednol suspension eye drops group developed corticosteroid-induced ocular hypertension, and were defined as prednisolone acetate group and loteprednol group. No significant differences were observed in the average intraocular pressure (IOP) at 1 week, 1 month, 3 months or 12 months postoperatively. There were significant differences in the average IOP between the two groups at 6 months postoperatively (P = 0.001). There were no significant differences in the average best corrected visual acuity (BCVA) at 1, 3 and 12 months postoperatively between two groups. The average 6-month postoperative BCVA was significantly higher in the prednisolone acetate group than the loteprednol group (P P > 0.05). Conclusions 0.5 % loteprednol suspension eye drops may be considered for long-term use after corneal transplantation.

Raymond Fong,1 Megan E Cavet,2 Heleen H DeCory,2 Jason L Vittitow31Manhattan Eye, Ear and Throat Hospital and Lenox Hill Hospital, New York, NY, USA; 2Medical Affairs, Bausch + Lomb, Rochester, NY, USA; 3Clinical Affairs, Bausch + Lomb, Bridgewater, NJ, USAPurpose: To evaluate the efficacy and safety of a submicron formulation of loteprednol etabonate (LE) gel 0.38% instilled three times daily (TID) compared with vehicle for the treatment of inflammation and pain following cataract surgery with intraocular lens implantation, integrated across two multicenter, double-masked, randomized, parallel-group, Phase III studies.Patients and methods: Subjects ≥18 years of age with anterior chamber (AC) cells ≥grade 2 (6–15 cells) on day 1 after cataract surgery were randomized to receive 1 drop of LE gel 0.38% TID, twice daily (not reported/analyzed herein), or vehicle instilled in the study eye for 14 days. Primary endpoints were the proportion of subjects with resolution of AC cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events (AEs), ocular signs, fundoscopy results, visual acuity, intraocular pressure (IOP), and tolerability (drop comfort and ocular symptoms).Results: The integrated intent-to-treat population included 742 subjects (LE gel 0.38% TID, n=371; vehicle, n=371). Significantly more subjects in the LE gel 0.38% TID group compared with the vehicle group had complete resolution of AC cells (29.6% vs 15.1%) and grade 0 pain (74.4% vs 48.8%) at day 8 (P75%) of subjects in each treatment group reported no drop discomfort. There were no reports of blurred vision with LE gel.Conclusion: The results of this integrated analysis indicate that LE (submicron) gel 0.38% administered TID is safe and effective for the treatment of ocular inflammation and pain following cataract surgery, with minimal risk of IOP elevation.Keywords: cataract surgery, postoperative pain, postoperative inflammation, loteprednol etabonate, submicron, integrated analysis

Objective We aimed to evaluate the safety and effectiveness of 2 dosing regimens of loteprednol etabonate (LE) ophthalmic gel 0.5% and bromfenac ophthalmic solution 0.07% in patients undergoing routine cataract surgery. Design Six-week prospective, masked, randomized controlled noninferiority study. Participants One hundred eyes. Methods Patients undergoing uncomplicated cataract surgery were selected in a consecutive manner. Patients were randomized to one of 2 groups: LE QID + qD bromfenac (control group) versus LE BID + qD bromfenac (study group). Primary outcome metrics included summed ocular inflammation score (SOIS) and adverse events. Secondary outcome measures included intraocular pressure, visual acuity, central retinal thickness, and subjective symptomology scores measured at 4 study visits. The final visit included a questionnaire addressing compliance, satisfaction, and comfort with the medications. Results Both groups demonstrated similar effectiveness and safety between dosing regimens. No statistically significant difference was reported between groups regarding SOIS (visit 1 p = N/A, visit 2 p = 0.66, visit 3 p = 0.60, visit 4 p = 0.08). No adverse events were reported relating to the difference in study regimen. A statistically significant difference was not found regarding secondary outcomes (p > 0.05). Control group patients reported a more difficult time remembering their doses for bromfenac but not LE (bromfenac p Conclusions Our data suggest that both groups had similar outcomes with respect to control of ocular inflammation with no differences in adverse outcomes. The compliance questionnaire also suggests a patient preference for the dosing regimen with lower frequency of drop application.

Terry Kim,1 Kenneth Sall,2 Edward J Holland,3 R Kim Brazzell,4 Susan Coultas,4 Preeya K Gupta1 1Department of Ophthalmology, Duke University Eye Center, Durham, NC, USA; 2Sall Research Medical Center, Inc, Artesia, CA, USA; 3Department of Ophthalmology, Cincinnati Eye Institute, University of Cincinnati, Cincinnati, OH, USA; 4Kala Pharmaceuticals, Inc, Waltham, MA, USA Purpose: KPI-121 is a nanoparticle suspension of loteprednol etabonate with improved ocular pharmacokinetics compared with marketed formulations. The efficacy and safety of KPI-121 1% ophthalmic suspension (INVELTYS™) dosed twice daily (BID) were evaluated in participants who had undergone cataract surgery. Materials and methods: In two multicenter, randomized, double-masked, parallel-group, vehicle-controlled clinical trials, 386 participants with ≥ grade 2 anterior chamber cells (≥6 cells) on the day following routine cataract surgery were treated with KPI-121 1% and 325 participants were treated with placebo (vehicle); each group was dosed BID for 2 weeks. Primary efficacy endpoints were complete resolution of ocular inflammation by slit-lamp biomicroscopy and complete resolution of subject-rated ocular pain at Days 8 and 15 with no rescue medication before Day 15. Safety assessments included adverse events (AEs), visual acuity, intraocular pressure measurements, and evaluation of ocular AEs by slit-lamp biomicroscopy and dilated ophthalmoscopy. Results: Both trials achieved statistical significance favoring KPI-121 1% BID for both primary efficacy endpoints. Combined data analysis showed that significantly more participants treated with KPI-121 vs vehicle achieved complete resolution of anterior chamber cells at Days 8 and 15 (P≤0.0001) and complete clearing of ocular pain at Days 4, 8, and 15 (P

Purpose: To evaluate the effect of tapered doses of loteprednol-etabonate in dry eye disease patients. Materials and methods: Dry eye and treatment outcomes were assessed by Schirmer I test, tear BUT, lissamine green conjunctival staining, fluorescein corneal staining, and HLA-DR expression on conjunctival cells. Patients received either loteprednol-etabonate 0.5% twice daily for 14 days tapered to once daily for 14 days, and then twice weekly for 28 days ( n = 10), or NaCl 0.9%. Results: A significant decrease of ocular surface inflammation and improvement of symptoms was recorded in the study group compared with controls at days 14 and 56. Change from baseline in HLA-DR expression in CD45+ conjunctival cells was significantly higher in treated patients at day 14. Intraocular pressure and best corrected visual acuity were preserved in all treated eyes. Conclusions: Tapered doses of loteprednol etabonate 0.5% suspension controlled ocular surface inflammation, improving dry eye symptoms.

Purpose To compare loteprednol etabonate (LE) gel 0.5% with prednisolone acetate suspension (PA) 1% for the treatment of inflammation after cataract surgery in children. Setting Eleven sites in the United States. Design Randomized, double-masked, parallel-group, noninferiority study. Methods Eligible patients were aged 11 years or younger and candidates for routine, uncomplicated cataract surgery. Patients were randomized to a 4-week postsurgical regimen with LE gel 0.5% or PA 1%, twice on the day of surgery, 4 times daily for 2 weeks, twice daily for 1 week, and once daily for 1 week. Assessments included anterior chamber (AC) cells/flare, anterior chamber inflammation (ACI), synechiae, precipitates on the intraocular lens/cornea, visual acuity, and intraocular pressure. Results The intent-to-treat population comprised 105 patients (LE gel, n = 53; PA 1%, n = 52) including 52 patients aged 3 years or younger. Patients achieved a similar mean ACI grade on postoperative day 14 (primary efficacy endpoint) whether treated with LE gel 0.5% or PA 1% (difference = 0.006, 2-sided 95% CI, -0.281 to 0.292). Similar ACI outcomes additionally were observed in patients aged 3 years or younger. LE gel 0.5% and PA 1% also appeared equally effective in resolving inflammation at all visits (days 7, 14, and 28 postsurgery), based on categorical distributions of ACI, AC cells, and AC flare scores/grades (P ≥ .06). Synechiae and corneal/IOL precipitates occurred infrequently with no significant differences between groups. No safety or tolerability concerns were identified, including no treatment-related IOP increases. Conclusions LE gel 0.5% was safe and effective in treating pediatric postcataract surgical inflammation, with similar outcomes as PA 1%.

Purpose The safety of KPI-121 0.25%, an ophthalmic nanoparticle suspension of loteprednol etabonate, was evaluated in subjects with dry eye disease (DED) in one phase 2 and three phase 3 randomized trials of similar design. Methods Adults with DED received KPI-121 0.25% or vehicle drops 4 times daily (QID) for ≥2 weeks; 1430 subjects received KPI-121 0.25% and 1438 subjects received vehicle drops. Main safety assessments were adverse events (AEs) and intraocular pressure (IOP). As a common side effect associated with the use of ocular corticosteroids is elevated IOP, subjects with a history of or current diagnosis of glaucoma were excluded. Results Instillation site pain was the most common AE, reported by 5.2% of subjects in the KPI-121 0.25% group and 4.4% of subjects in the vehicle group; other AEs were reported by ≤0.8% of subjects in the KPI-121 group. IOP elevations, a side effect associated with the use of ophthalmic corticosteroids, were observed with low incidence: 0.6% and 0.2% of subjects in the KPI-121 and vehicle groups, respectively. An IOP elevation was defined as an increase from baseline of >5 mm Hg that resulted in an IOP of ≥21 mm Hg in either eye during use of the study product. Conclusions KPI-121 ophthalmic suspension 0.25% seemed to be safe and well tolerated when dosed QID for 2 to 4 weeks in those DED subjects included in the 4 trials.

WOS: 000532888800001 PubMed: 32409942 Purpose To evaluate the effects of loteprednol etabonate on cornea and tear film in patients with seasonal allergic conjunctivitis by anterior segment optical coherence tomography (OCT). Methods The right eyes of 52 subjects with seasonal allergic conjunctivitis were evaluated in the study. Central corneal thickness (CCT), the thicknesses of central corneal epithelium (CET) and central non-epithelial cornea (CnET), and lower and upper tear meniscus areas were measured by spectral-domain OCT and ocular surface disease index (OSDI) were obtained at baseline. After topical use of loteprednol etabonate 0.5% eye drop three times a day for 1 week, the measurements were repeated. Paired T test was used for analysis. Results Mean CCT and mean thicknesses of CET and CnET at baseline were 528.19 +/- 34.47 mu m, 64.10 +/- 5.30 mu m and 462.84 +/- 33.43 mu m, respectively, and these were 526.31 +/- 33.37 mu m, 64.65 +/- 4.84 mu m and 459.84 +/- 32.11 mu m after the treatment, respectively. OSDI score was 21.55 +/- 4.40 at baseline and 13.13 +/- 2.39 after 1 week. The lower and upper tear meniscus areas at baseline were 0.026 +/- 0.017 mm(2) and 0.017 +/- 0.007 mm(2), respectively, and they were 0.017 +/- 0.009 mm(2) and 0.016 +/- 0.007 mm(2), respectively, after the treatment. There is statistically significant difference between before and after values of CCT, CnET, lower tear meniscus area and OSDI score (p < 0.05). Conclusion There is no change in corneal epithelial thickness and upper tear meniscus area after 1-week treatment with loteprednol etabonate in patients with seasonal allergic conjunctivitis, but it may cause decrease in non-epithelial corneal thickness and lower tear meniscus area.

To assess the safety and efficacy of a 0.38% submicron formulation of loteprednol etabonate (LE) gel for the treatment of postoperative inflammation and pain after cataract surgery.Forty-five United States ophthalmology practices.Double-masked vehicle-controlled randomized parallel group study.Patients 18 years of age or older with anterior chamber cells grade 2 or higher on day 1 after uncomplicated cataract surgery were randomized to 14 days of treatment with LE gel 2 times a day, LE gel 3 times a day, or vehicle. Hierarchical primary endpoints were the proportion of patients with resolution of anterior chamber cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events, intraocular pressure (IOP), biomicroscopy, visual acuity, ophthalmoscopy, and tolerability (drop comfort and ocular symptoms).The intent-to-treat population included 514 patients. Significantly more patients in the LE gel 2 times a day and 3 times a day groups compared with the vehicle group had complete resolution of anterior chamber cells (26.9% and 28.7% versus 9.3%) and reported grade 0 pain (73.7% and 73.1% versus 47.7%) on day 8 (P .001 vs vehicle for all). The safety findings were unremarkable, with 1 patient experiencing an IOP increase of 10 mm Hg or higher while on LE gel. More than 75% of patients in each group reported no drop discomfort.In this study, submicron loteprednol etabonate gel 0.38% appeared safe and effective in the treatment of postoperative inflammation and pain whether instilled 2 times or 3 times a day.

To compare the effects of topical loteprednol and fluorometholone in children who underwent strabismus surgery.This is a retrospective observational case series. A total of 60 Korean children who underwent strabismus surgery between January 2016 and September 2016 were included. Patients were prescribed topical loteprednol etabonate 0.5% or fluorometholone 0.1% until 3 weeks after surgery. Four parameters (intraocular pressure [IOP], conjunctival injection, conjunctival inflammation, and patient discomfort) were assessed every week for up to 4 weeks after surgery. Main outcome measures were comparison of parameters between the 2 groups at each following week after surgery. In addition, factors associated with clinically meaningful IOP elevation were evaluated.IOP was significantly elevated at the second and third postoperative week compared with baseline (P = 0.028 and 0.001) in the loteprednol group but not significantly in the fluorometholone group. The mean IOP of the loteprednol group at 1 and 3 weeks after surgery were significantly higher than that of the fluorometholone group (P = 0.032 and 0.017, respectively). Multivariate analysis revealed that age ≤8 years (odds ratio 14.52, 95% confidence interval 1.16-139.05) was associated with IOP21 mmHg. There was no significant difference between the 2 groups in patient discomfort, conjunctival inflammation, and conjunctival injection.Loteprednol and fluorometholone showed similar anti-inflammatory effect after strabismus surgery in children. Loteprednol appeared to have more effect on IOP elevation than fluorometholone, especially in children ≤8 years of age. When treating young patients with loteprednol, clinicians should be aware of IOP elevation.

Mahmoud A Khaimi Dean McGee Eye Institute, Oklahoma City, OK, USA Background: While loteprednol etabonate (LE) suspension 0.5% is approved for the treatment of postoperative ocular inflammation, there have been no reported studies of its use in glaucoma patients undergoing canaloplasty.Methods: This was a retrospective medical chart review conducted at a single US center. Data were collected on patients with glaucoma who underwent canaloplasty with or without cataract surgery, and were prescribed LE suspension 0.5% postoperatively. Outcomes evaluated included postsurgical inflammation (anterior chamber [AC] cells and flare), intraocular pressure (IOP), number of IOP-lowering medications, and postsurgical complications.Results: Data were collected on 204 patients (262 eyes) with a mean (SD) age of 71.6 (11.3) years. The most frequent LE dosing regimens at day 1, week 1, and month 1 postsurgery were QID (92.3%; 241/261), TID (52.6%; 133/253), and QD (65.5%; 78/119), respectively. Inflammation (AC flare and cells), mostly mild, was noted in 33.2% (86/259) of eyes on postoperative day 1 and 8.6% (21/244) of eyes at month 1. Mean IOP and mean number of IOP-lowering medications were significantly reduced from baseline (P

PURPOSE The main purpose of this study was to report a case of panscleritis after gonioscopy-assisted transluminal trabeculotomy (GATT). METHODS We describe the case of a 33-year-old man with a history of unilateral anterior uveitis and glaucoma, who developed panscleritis after GATT surgery. RESULTS Uneventful GATT surgery was performed in a glaucomatous left eye. On the second postoperative day, the patient developed tenderness on palpation of the eye. Ophthalmic examination revealed significant diffuse hyperemia, elongated and tortuous upper bulbar conjunctival/scleral vessels, and exudative retinal detachment at the superior nasal quadrant, with diffuse scleral thickening. The patient was diagnosed as having panscleritis, which was attributed to the GATT surgery. Although the scleritis resolved completely with intravenous and oral methylprednisolone treatment, localized retinal detachment persisted. CONCLUSIONS Surgery-induced posterior scleritis may occur following minimally invasive glaucoma surgeries such as GATT. Control of uveitis for at least 3 months before surgery is indicated in patients with uveitis if GATT surgery is planned.

To compare the efficacy and safety of postoperative topical loteprednol etabonate (LE) 0.5% with dexamethasone (DEX) 0.1% for the treatment of inflammation following pars plana vitrectomy (PPV).A total of 150 eyes of 150 patients who underwent transconjunctival PPV for various diagnoses were included in this prospective, randomized study. The patients were assigned into two groups as Group LE (n = 75) and Group DEX (n = 75). Intraocular inflammation, intraocular pressure (IOP), and the intensity of postoperative pain were compared between the groups.The mean IOP was higher in the patients treated with DEX (p 0.05). The need for anti-glaucoma medications was significantly lower in Group LE (5.3%) than in Group DEX (17.3%) (p = 0.020). Tyndall scores were less in Group DEX at postoperative Days 1 (p = 0.01) and 3 (p = 0.017). On Day 1, it was more likely for patients to have mild or moderate pain in Group LE (p 0.001). On Day 3, the number of the patients with no pain was higher in Group DEX (p = 0.005).Although DEX is more effective in the early postoperative days, LE appears to be as effective in controlling inflammatory response following PPV in the long-term. Topical LE is associated with less increase in the IOP and a lower need for anti-glaucoma medications.

PURPOSE: The study aims to evaluate the safety of topical corticosteroids Loteprednol and Flurometholone in treating VKC keeping in mind the efcacy of the drugs. METHOD: A prospective study was done including 200 eyes of 107 patients with severe VKC (grade 3,4). 7 patients were lost during follow up. Patients were selected randomly. 100 eyes of 50 patients were treated with Flurometholone 1% and another 100 eyes of 50 patients with Loteprednol 0.5%. All patients were followed up over a period of 3 months. The study duration is 18 months. RESULT: The normal IOP ranging between 10-21 mm Hg. Out of 100 eyes receiving urometholone in the study period of 18 months, 3 eyes (3%) showed IOP ≥ 30mm Hg and 5 eyes (5%) showed IOP between 21-30mm Hg. Out of the rest 100 eyes receiving Loteprednol, 3 eyes (3%) showed IOP between 21-30 mm Hg while none (0%) reached an IOP over 30 mm Hg. CONCLUSION: Loteprednol is more effective than Flurometholone and it consistently demonstrated a low propensity to elevate IOP, regardless of formulation, dosage regimen both during short term as well as long term treatment of VKC patient.

PURPOSE To report a case of successful intraocular pressure (IOP) reduction after a 360-degree gonioscopy-assisted transluminal trabeculotomy (GATT) using the iTrack catheter in a patient with steroid-induced glaucoma as a result of treatment of vernal keratoconjunctivitis (VKC). MATERIALS AND METHODS Case report. RESULTS An 8-year-old male individual with a long-standing history of VKC, treated with topical steroids, developed elevated IOP and glaucoma in the right eye despite maximum topical glaucoma therapy. Reducing the steroid was not a viable option given the severity of VKC. A 360-degree GATT was successfully performed and IOP has been maintained off all glaucoma drops. CONCLUSIONS GATT is a viable option for steroid-induced glaucoma in the pediatric population. This obviates the need for riskier, more invasive conjunctival-based procedures.

JD Sheppard,1 IP Singh21Department of Ophthalmology, Eastern Virginia Medical School, Norfolk, VA, USA; 2Department of Glaucoma, The Eye Centers of Racine & Kenosha, Racine, WI, USAPurpose: With the increasing use of minimally invasive surgical techniques for intraocular pressure (IOP) lowering in glaucoma patients, there is a need to examine best practices regarding the postoperative management of these patients. Corticosteroids, though effective in controlling postoperative ocular pain and inflammation, present distinct challenges in glaucoma surgery patients, as their use can be associated with IOP elevation. Loteprednol etabonate (LE) is an ocular corticosteroid designed to have an improved safety profile relative to other corticosteroids.Methods: We report here a representative selection of cases in which patients were successfully treated with LE ophthalmic gel 0.5% (LE gel) following a variety of minimally invasive glaucoma surgery (MIGS) procedures. Cases included patients undergoing various procedures including a Trabectome combined with cataract surgery; micro-stent surgery (iStent) combined with cataract surgery; supraciliary CyPass Micro-Stent placement combined with cataract surgery; Kahook Dual Blade goniotomy; and ab interno canaloplasty using the iTrack catheter.Observations: In all cases, use of LE gel during the postoperative period appeared effective and safe in reducing inflammation and controlling pain. No adverse events or IOP elevations were noted, even in those patients continuing use of LE gel past the postoperative period for longer than six months with documented follow-up. In two cases, patients with elevated IOP using either prednisolone or difluprednate postoperatively were switched to LE gel, with a subsequent reduction in IOP.Conclusions: This selection of cases involving patients undergoing MIGS suggests that LE gel may be an effective and safe option for treating postoperative inflammation and pain following such procedures with minimal to no effect on IOP or other negative sequalae.Keywords: loteprednol etabonate, minimally invasive glaucoma surgery, intraocular pressure, postoperative pain and inflammation, safety

PURPOSE To study the effect of periocular steroid use on intraocular pressure (IOP). METHODS Charts of adult patients with atopic dermatitis or eczema treated with topical periocular steroid creams and ointments from January 1st, 2007 to October 1st, 2017 were reviewed. Patients with the following were excluded: glaucoma, ocular hypertension, known systemic/topical/injectable steroid history, and lack of documented IOP prior to or during treatment with periocular steroid ointment. Patient data were collected regarding gender, treatment regimen, as well as IOP prior to and during treatment. Steroid responders were identified. Statistical analysis was performed using linear mixed effects models adjusting for follow-up time to test the relationship between pre and posttreatment IOP change adjusting for intereye correlations. RESULTS Thirty-one patients were identified. Twenty-one were treated bilaterally and 10 unilaterally. Five patients were glaucoma suspects. The mean treatment period was 14.2 weeks with a range of 0.1-83.9 weeks. Patients were treated with fluorometholone (42%), loteprednol etabonate (23%), dexamethasone-neomycin-polymyxin B (13%), hydrocortisone 1% or 2.5% (3%), and tobramycin-dexamethasone (19%). In the combined sample, there was no significant IOP change even after adjusting for follow-up time (mean change: +0.44 mm Hg, p = 0.126). However, eyes with baseline IOP ≥ 14 mm Hg had a significant increase (+0.73 mm Hg/year, p = 0.032). Individual steroid responses included the following: 1 intermediate and 30 low responders, of which 19 patients had an IOP change of

Loteprednol etabonate ophthalmic gel 0.38% (Lotemax

Purpose: Patients with absent iris crypts are the most challenging cases for performing laser peripheral iridotomy. This study was conducted on patients of primary angle closure disease belonging to this group to find out the difference in the quantum of energy and number of attempts required to achieve optimum peripheral iridotomy by sequentially using double frequency Nd:YAG and Nd:YAG laser versus Nd:YAG laser alone. Methods: Forty eyes of 40 patients of 35 years or more, with primary angle closure disease and absent iris crypts, in whom laser peripheral iridotomy (LPI) was indicated, were prospectively randomized into two groups. Patients in group one sequentially underwent double frequency Nd:YAG & Nd:YAG laser and group two underwent Nd:YAG laser alone. Follow up was done one hour, three hours, one day and one week post laser. Any rise of IOP of > 8 mmHg from base line or an absolute figure of 30 mmHg at any visit was considered significant. Post laser topical loteprednol etabonate 4 times per day for one week and pilocarpine nitrate 2% eye drops twice a day for five days were used in all cases. Statistical testing was conducted with the statistical package for the social science system (SPSS) version 17.0. Results: Group one had 3 male and 16 female patients whereas group two had 9 and 12 male and female patients respectively. Nd:YAG energy required in group one (n=19) was 48.79 ± 19.41 mJ and in group two (n=21) was 88.81 ± 37.36 mJ (p=

Purpose: To compare the efficiency and ocular side-effect profile of topical loteprednol applied to one eye and topical dexamethasone applied to the other eye in the early period on the same patient who has subepithelial infiltrates (SEI).Methods: The patients who developed bilateral SEI following epidemic keratoconjunctivitis (EKC) were applied topical loteprednol on one eye (group 2) and topical dexamethasone on the other (group 1).Results: Decrease in the symptoms was faster in the dexamethasone group, but this difference between the groups was not statistically significant (p = 0.073). Both groups were found to have substantial recurrence. However, the difference between the groups was not statistically significant (p = 0.131).Conclusions: The study has found that in the treatment of SEI, which developed after EKC, statistically similar results can be obtained with loteprednol, which is known to have fewer adverse effects.

Purpose: To compare the efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) and dexamethasone 0.1%/tobramycin 0.3% (DM/T) ophthalmic suspensions in reducing select signs of blepharitis.Methods: Data were pooled from two studies (one from the USA; one from China) of adults (n = 627) with blepharokeratoconjunctivitis treated with LE/T or DM/T four times daily for 2 weeks (safety population). Efficacy analyses included 495 eyes (247 LE/T, 248 DM/T) with any baseline sign of blepharitis.Results: At Day 15, the least squares mean change from baseline in composite blepharitis severity was similar between LE/T (–2.86) and DM/T (–2.99) (90% CI for mean treatment difference: –0.35, 0.11). Intraocular pressure (IOP) increases ≥10 mmHg over baseline were reported for 1 US patient (DM/T group) and 19 Chinese patients (6 LE/T; 13 DM/T).Conclusions: LE/T was similarly effective in reducing the signs of blepharitis compared with DM/T, but demonstrated a better safety profile with respect to changes in IOP.

To compare the anti-inflammatory efficacy and safety of 0.5% loteprednol etabonate/0.3% tobramycin (LE/T) and 0.1% dexamethasone/0.3% tobramycin (DM/T) ophthalmic suspensions following strabismus surgery.The records of 40 patients who were treated with either LE/T or DM/T following strabismus surgery were retrospectively reviewed. The recorded signs and symptoms of inflammation and intraocular pressure of the patients at 1 day, 1 week, and 3 weeks after the surgery were evaluated and compared between the groups.In both groups, reduced inflammation was noted during the follow-up visits. There was no statistically significant difference between the LE/T and DM/T groups with regard to the postoperative scores or measurements, including discomfort, chemosis, secretion, conjunctival hyperemia, and conjunctival gap size (p0.05), during the follow-up visits. Allergic reactions to the medications were not reported in any patient. Intraocular pressures were within normal limits in both groups.LE/T was found to be as effective as DM/T in reducing inflammation after strabismus surgery. LE/T, as a new-generation steroid combination product, could be used as a safe and effective anti-inflammatory agent for the treatment of inflammation following strabismus surgery.Şaşılık cerrahisi sonrası loteprednol etabonat %0,5/tobramisin %0,3 (LE/T) ve deksametazon %0,1/tobramisin %0,3 (DM/T) oftalmik solüsyonlarının antiinflamatuar etkinlik ve güvenliğinin karşılaştırılması.Şaşılık cerrahisi sonrası, LE/T veya DM/T ile tedavi uygulanmış 40 hastanın kayıtları retrospektif olarak gözden geçirildi. Hastaların cerrahi sonrası 1. gün, 1. ve 3. haftalarda kaydedilen göz içi basınçları, enflamasyona ait semptom ve bulguları değerlendirildi ve gruplar arasında karşılaştırma yapıldı.Her iki grupta, takiplerde enflamasyonun azaldığı değerlendirildi. Operasyon sonrası, LE/T ve DM/T grupları arasında, rahatsızlık hissi, kemozis, sekresyon, konjonktival hiperemi skorları ve konjonktiva açıklık değerleri açısından istatistiki olarak anlamlı bir fark tespit edilmedi. (p0.05) Hastaların hiçbirisinde alerjik reaksiyon rapor edilmemişti. Göz içi basınçları her iki grupta da normal sınırlar içerisindeydi.LE/T’nin, DM/T kadar şaşılık cerrahisi sonrası inflamasyonun azaltmasında etkin olduğu; yeni jenerasyon steroid kombinasyon ürünü olarak, güvenli ve etkili olarak kullanılabileceği kanaatine varıldı.

To better understand the nature of periocular dermatitis (PD) patient presentation, treatment, time-to-cure, and referral pattern for allergy testing in an ophthalmic academic center.A retrospective chart review of 344 patients diagnosed with PD between January 1, 2000 and November 30, 2016 at the Edward S. Harkness Eye Institute was performed. Eighty patients were eligible for the study. The primary endpoint was the time-to-cure. Cox proportional hazards regression was performed to assess if there was a significant difference between time-to-cure in patients treated with: 1) combination topical steroid/antibiotic (n = 6) vs. topical steroid alone (n = 40) and 2) combination topical steroid and oral antihistamine (n = 5) vs. topical steroid alone (n = 40).The median age of eligible patients was 57.69 years old, 66.25% of patients were female, and 41.25% had a history of atopy. Seven patients in total were referred for allergy testing. A significant difference was found in likelihood of cure when comparing combination topical steroid and oral antihistamine versus topical steroid alone, adjusting for age and gender (aHR = 3.97, 95% CI: 1.40-11.25). No significance was found when comparing combination topical steroid/antibiotic versus topical steroid alone (aHR = 1.96, 95% CI: 0.72-5.27).Patients treated with topical steroid and oral antihistamine were approximately 4 times more likely to experience cure in comparison to patients treated with topical steroids alone. While the majority of patients were not referred for formal allergy testing, this would likely be of benefit.

Prevention and management of postoperative ocular inflammation with corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs) have been evaluated in several randomised controlled trials (RCTs). However, neither consensus regarding the efficacies of different regimens nor established guidelines are currently available. This has resulted in different practice patterns throughout the world. A systematic literature review found that for the management of postcataract inflammation nepafenac produced a positive outcome in three of three RCTs (3/3), as did ketorolac (1/1), bromfenac (7/7), loteprednol (3/3) and difluprednate (6/6), but not flurbiprofen (0/1). A single study found that betamethasone produced inconclusive results after retinal detachment (RD) surgery; ketorolac was effective (1/1) after vitrectomy, but triamcinolone was ineffective (0/1) after trabeculectomy. A two-round Delphi survey asked 28 international experts to rate both the inflammatory potential of different eye surgeries and their agreement with different treatment protocols. They rated trabeculectomy, RD surgery and combined phacovitrectomy as more inflammatory than cataract surgery. Vitrectomies for macular hole or epiretinal membrane were not deemed more inflammatory than cataract surgery. For trabeculectomy, they preferred to treat longer than for cataract surgery (NSAID + corticosteroid three times a day for 2 months vs 1 month). For vitrectomy alone, RD surgery and combined phacovitrectomy, the panel preferred the same treatment as for cataract surgery (NSAID + corticosteroid three times a day for 1 month). The discrepancy between preferred treatment and perception of the eye's inflammatory status by the experts for RD and combined vitreoretinal surgeries highlights the need for RCTs to establish treatment guidelines.

To compare intraocular pressure (IOP) elevation and graft rejection with loteprednol etabonate 0.5% gel and prednisolone acetate 1% solution after Descemet membrane endothelial keratoplasty (DMEK).In this prospective, evaluator-masked trial, 167 patients were randomized to loteprednol or prednisolone in a 1:1 ratio 1 month after DMEK; 66 fellow eyes were enrolled and assigned to the opposite treatment. Dosing was 4 times daily for 2 months, thrice daily for 1 month, twice daily for 1 month, and once daily for 7 months. The main outcomes were IOP elevation (defined as IOP ≥ 24 mm Hg or an increase of ≥10 mm Hg over the baseline preoperative level) and immunologic rejection episodes, assessed by Kaplan-Meier survival analysis and proportional hazards modeling.A total of 233 eyes were assigned to treatment. Loteprednol etabonate 0.5% gel and prednisolone acetate 1% solution were equally effective in preventing immunologic rejection episodes; none (0%) occurred with either treatment (P = 1). IOP elevation was twice as likely in the prednisolone-treated eyes (relative risk = 2.3, 95% confidence interval: 1.2-4.5, P = 0.016). The proportion with IOP elevation was 25% in prednisolone-treated eyes versus 11% in loteprednol-treated eyes (P = 0.013). In 66 subjects with fellow eyes assigned to opposite treatments, an IOP increase of ≥10 mm Hg was significantly more likely in the prednisolone-treated eye (P = 0.031).Loteprednol etabonate 0.5% gel was as effective as prednisolone acetate 1% solution in preventing immunologic graft rejection episodes after DMEK and was significantly less likely to cause IOP elevation.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01853696.

This retrospective study was performed to analyze the long-term outcome of topical corticosteroid treatment for severe dry eye associated with Sjogren's syndrome (SS). Patients who had severe dry eye associated with SS were topically treated with loteprednol etabonate 0.5% (group A, n=66) or fluorometholone 0.1% (group B, n=67) twice daily and were followed up for 2 years. Visual acuity (VA), intraocular pressure (IOP), Schirmer test, tear film breakup time (BUT), keratoepitheliopathy, and symptom scores were measured at baseline and 6, 12, 18, and 24 months after treatment. VA and IOP were not changed significantly during follow-up in either group. Schirmer test results, keratoepitheliopathy, and symptom scores at 6, 12, 18, and 24 months (p

To compare loteprednol etabonate 0.5%/tobramycin 0.3% (Zylet(®)) with dexamethasone 0.1%/tobramycin 0.3% (Tobradex(®)) in terms of the epithelial healing time, postoperative visual acuity, corneal haziness score, and intraocular pressure (IOP) in postoperative treatment after photorefractive keratectomy (PRK).This prospective, randomized, double-masked (participants and assessors blinded) controlled study included 32 patients who underwent PRK. The patients were allocated equally into 2 groups by block randomization to receive either loteprednol etabonate (Lot) or dexamethasone (Dex) for 1 month after the surgery. The epithelial healing time, uncorrected visual acuity (UCVA), corneal haziness score, and IOP were evaluated at 1 week, 1 month, and 3 months.The corneal epithelium was healed within 3 days in both groups; however, the epithelium was closed on the second day in 3 cases in the Lot group compared with 1 case in the Dex group. No significant differences were found for UCVA at 1 and 3 months (Fisher exact test, P0.01). Similarly, there was no statistically significant difference in corneal haziness scores between the 2 groups at 1 and 3 months (Mann-Whitney U test, P0.05). The number of patients experiencing significantly increased IOP (≥5 mmHg) from baseline at any visit for the Lot group (1/16 patients) was fewer than for the Dex group (3/16 patients).Loteprednol etabonate was effective in postoperative PRK management and was significantly less likely to produce elevations in IOP than was dexamethasone.

To compare the outcomes and complications of topical difluprednate 0.05% and loteprednol gel 0.5% after routine cataract surgery.Subjects received either difluprednate emulsion 0.05% (n=30 eyes) or loteprednol gel 0.5% (n=30 eyes) after routine cataract surgery. Topical steroid drops were initiated 3 days before cataract surgery and continued for 2 weeks postoperatively. Anterior chamber (AC) cell grade, corneal edema, corneal pachymetry, visual acuity, ocular surface quality (Oxford scale), and intraocular pressure (IOP) were evaluated at 1 day, 1 week, and 1 month postoperatively.Patients treated with difluprednate or loteprednol had statistically similar resolution of their AC cell grade and corneal edema at 1 day, 1 week, and 1 month postoperatively (P0.05 at each study visit). Difluprednate-treated and loteprednol-treated eyes achieved a mean best-corrected visual acuity of at least 20/25 by 1 week postoperatively (0.055 and 0.061 logarithm of the minimum angle of resolution, respectively; P=0.82). The nasal ocular surface quality at 1 week had improved in loteprednol-treated eyes compared with difluprednate-treated eyes (1.0 vs. 1.9 Oxford score, respectively; P0.001), but similar at all other visits. There was no statistical difference between IOP levels between both treatment groups (P0.05). In the difluprednate-treated group, one patient developed rebound inflammation and two patients developed cystoid macular edema at their 1-month postoperative visit.The anti-inflammatory effect, visual recovery, and IOP of patients using topical difluprednate or loteprednol gel after cataract surgery are equivalent. There may be an additional short-term benefit of loteprednol gel in protecting the ocular surface after cataract surgery.

Background Blepharokeratoconjunctivitis (BKC) is a type of inflammation of the surface of the eye and eyelids that involves changes of the eyelids, dysfunction of the meibomian glands, and inflammation of the conjunctiva and cornea. Chronic inflammation of the cornea can lead to scarring, vascularisation and opacity. BKC in children can cause significant symptoms including irritation, watering, photophobia and loss of vision from corneal opacity, refractive error or amblyopia. Treatment of BKC is directed towards modification of meibomian gland disease and the bacterial flora of lid margin and conjunctiva, and control of ocular surface inflammation. Although both topical and systemic treatments are used to treat people with BKC, this Cochrane review focuses on topical treatments. Objectives To assess and compare data on the efficacy and safety of topical treatments (including antibiotics, steroids, immunosuppressants and lubricants), alone or in combination, for BKC in children from birth to 16 years. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE ( January 1946 to 11 July 2016), Embase (January 1980 to 11 July 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 11 July 2016. We searched the reference lists of identified reports and the Science Citation Index to identify any additional reports of studies that met the inclusion criteria. Selection criteria We searched for randomised controlled trials that involved topical treatments in children up to 16 years of age with a clinical diagnosis of BKC. We planned to include studies that evaluated a single topical medication versus placebo, a combination of treatments versus placebo, and those that compared two or multiple active treatments. We planned to include studies in which participants received additional treatments, such as oral antibiotics, oral anti-inflammatories, warm lid compresses and lid margin cleaning. Data collection and analysis Two review authors independently screened the results of the literature search (titles and abstracts) to identify studies that met the inclusion criteria of the review and applied standards as expected for Cochrane reviews. We graded the certainty of the evidence using GRADE. Main results We included one study from the USA that met the inclusion criteria. In the study, 137 children aged zero to six years old with blepharoconjunctivitis were randomised to treatment in one of four trial arms (loteprednol etabonate/tobramycin combination, loteprednol etabonate alone, tobramycin alone or placebo) for 15 days, with assessments on days 1, 3, 7 and 15. We judged the study to be at high risk of attrition bias and bias due to selective outcome reporting. The study did not report the number of children with improvement in symptoms nor with total or partial success as measured by changes in clinical symptoms. All children showed a reduction in blepharoconjunctivitis grade score, but there was no evidence of important differences between groups. Visual acuity was not fully reported but the authors stated that there was no change in visual acuity in any of the treatment groups. The study reported ocular and non ocular adverse events but was underpowered to detect differences between the groups. Ocular adverse events were as follows: loteprednol/tobramycin 1/34 (eye pain); loteprednol 4/35 (eye pain, conjunctivitis, eye discharge, eye inflammation); tobramycin 0/34; placebo (vehicle) 0/34. The evidence was limited for all these outcomes and we judged it to be very low certainty. There was no information on clinical signs (aside from grade score), disease progression or quality of life. Authors' conclusions There is no high-quality evidence of the safety and efficacy of topical treatments for BKC, which resulted in uncertainty about the indications and effectiveness of topical treatment. Clinical trials are required to test efficacy and safety of current and any future treatments. Outcome measures need to be developed which can capture both objective clinical and patient-reported aspects of the condition and treatments.

Purpose: The aim of this study was to compare the ocular hypertensive effect of the commercially available Betamethasone, Fluorometholone in Iran and Loteprednol Etabonate in patients undergoing keratorefractive surgery. Methods: In this prospective randomized clinical trial, 300 eyes of 150 patients were included, and patients were randomly assigned to 3 groups and used one of the 3 steroid drops (Betamethasone 0.1%, Fluorometholone 0.1%, and Loteprednol Etabonate 0.5%) after myopic photorefractive keratectomy (PRK). Intraocular pressure (IOP) was measured 2, 4, and 6 weeks post-surgery. Twenty-two mmHg was set as the threshold IOP for starting anti-glaucoma medication and tapering steroid drops. Results: Of 300 eyes from 150 patients over the first 6 postoperative weeks, 2 eyes in Fluorometholone group (2%), 12 eyes in Betamethasone group (12%), and 16 eyes in Loteprednol group (16%) had IOP equal or more than 22 mmHg. Analysis of variance (ANOVA) test showed that the rise in IOP was significantly different between groups in the 2nd and 4th (P ≤ 0.001) postoperative weeks but not at 6th week (P = 0.230). An IOP rise equal or more than 10 mmHg was detected in 13 and 15 eyes in Betamethasone and Loteprednol groups, respectively. None of the eyes in Fluorometholone group had such an IOP rise. Conclusions: Loteprednol and Fluorometholone were associated with the most and least increase in IOP, respectively. The highest pressures were detected 4 weeks after surgery in the Betamethasone and Loteprednol groups and 6 weeks after surgery in the Fluorometholone group. Fluorometholone was the safest among the three examined steroid drops in terms of IOP rise. Keywords: Steroid induced glaucoma, Loteprednol etabonate, Keratorefractive surgery, Photorefractive keratectomy

Objective: The purpose of this work was to evaluate the effect of loteprednol etabonate (LE) before the initiation of topical cyclosporine A (tCsA) therapy in patients with mild-to-moderate dry eye disease. Prospective, multicenter randomized double-masked parallel group clinical study (NCT00407043). Methods: Hundred and eighteen patients with dry eye disease were randomized to receive either LE and tCsA (n=61) or artificial tears (AT) and tCsA (n=57). Hundred and twelve patients completed the study (LE: n=57, AT: n=55) and are included in the data analysis. Patients selfadministered either LE or AT for 2 weeks 4 times per day, followed by tCsA twice per day accompanied by either LE twice per day or AT twice per day for an additional 6 weeks of treatment. Primary outcome measures included the Ocular Surface Disease Index (OSDI) questionnaire, the Likert scale using standardized facial expressions, lissamine green staining, fluorescein staining, and the Schirmer test. Additional measures included global self-assessment, and safety outcomes included slitlamp examination, intraocular pressure, and assessment of visual acuity. Results: Loteprednol etabonate pretreatment significantly reduced tCsA stinging (P,0.05). Both groups showed significantly improved OSDI scores at the 14-, 30-, and 60-day visits. Loteprednol etabonate showed significantly more OSDI improvement than AT. Both pretreatment strategies improved global self-assessment scores, Schirmer test, fluorescein staining, lissamine staining, and adjunctive AT use. Loteprednol etabonate showed superior improvement in Schirmer test, fluorescein staining, and lissamine staining. Intraocular pressure did not increase in either group. Conclusions: Loteprednol etabonate induction therapy 2 weeks before the initiation of long-term tCsA treatment for chronic dry eye disease provides more rapid relief of dry eye signs and symptoms with greater efficacy than tCsA and AT alone.

A new gel formulation containing loteprednol etabonate (LE), a C-20 ester corticosteroid used to treat ocular inflammation, was developed to provide increased retention on the ocular surface for improved drug delivery to intraocular tissues. This investigation evaluated concentrations of LE in tear fluid following topical instillation of LE gel to humans and the ocular and systemic pharmacokinetics of LE following administration to rabbits.LE ophthalmic gel 0.5% was administered as a single topical dose to human volunteers (n=12) and Dutch Belted rabbits (n=40). In the human study, tear sampling was performed at 6, 9, 12, and 24 h after instillation. In the rabbit study, tears and ocular tissues were collected from 5 min through 24 h postdose. Serial blood samples were collected from one cohort of rabbits for plasma analysis. Concentrations of LE were determined by high performance liquid chromatography tandem mass spectrometry.In humans, LE was detected in tears at all the time points assessed with mean concentrations of 114 μg/g at 6 h declining to 2.41 μg/g at 24 h postdose. In rabbits, LE was detected in all ocular tissues within 5 min after dosing. Maximum concentrations of LE were achieved within 0.5 h and were highest in tear fluid (1560 μg/g), followed by bulbar conjunctiva (4.03 μg/g), cornea, (2.18 μg/g), iris/ciliary body (0.162 μg/g), and aqueous humor (0.0138 μg/mL). LE remained measurable in all ocular tissues through 24 h with the exception of aqueous humor. In contrast, plasma levels of LE were low with no detectable levels after 4 h.The gel formulation of LE provided prolonged exposure to LE on the ocular surface, with measurable levels in tears through 24 h in both humans and rabbits, for delivery of LE to anterior segment tissues, as evidenced by sustained levels of LE in rabbit conjunctiva, cornea, and iris/ciliary body.

PurposeTo assess tear cytokine levels and clinical outcomes in meibomian gland dysfunction (MGD) in the blind eye of patients wearing an ocular prosthesis after 2 months of treatment with topical loteprednol etabonate and eyelid scrubs with warm compresses.Patients and methodsThis study included patients with MGD wearing a unilateral ocular prosthesis for more than 1 year. All patients topically received 0.5% loteprednol etabonate and were instructed to scrub their eyelids with warm compresses on the prosthetic eye for 2 months. We evaluated tear cytokine levels using Multiplex Bead Immunoassays, performed biomicroscopic examination of the lid margins and meibomian gland, conducted meibography imaging, and assessed MGD-related ocular symptoms using a questionnaire for the prosthetic eye before and 2 months after treatment.ResultsThirty consecutive patients were included. There were significant reductions in the levels of interleukin (IL)-6, interferon-γ, monocyte chemotactic protein-1, IL-8, tumor necrosis factor-α, and IL-1β (P

Background:Cost-related nonadherence to medication can impact ophthalmic treatment outcomes. We aimed to determine whether medication prices vary between US cities and between different types of pharmacies within one city.Methods:We conducted a phone survey of eight nationwide and five independent pharmacies in five cities across the United States: Boston, Massachusetts; Charlotte, North Carolina; Denver, Colorado; Detroit, Michigan; and Seattle, Washington. A researcher called each pharmacy asking for price without insurance for four common anti-inflammatory ophthalmic medications: prednisolone acetate, prednisolone sodium phosphate, difluprednate (Durezol™), and loteprednol etabonate (Lotemax™).Results:Prednisolone sodium phosphate price could only be obtained by a small subset of pharmacies (45.2%) and was excluded from additional analysis; however, preliminary data demonstrated lower cost of prednisolone sodium phosphate over prednisolone acetate. Three-way analysis of variance revealed no interaction between pharmacy type (chain versus independent), city, and drug ( F = 0.40, p = 0.92). A significant interaction was identified between pharmacy type and drug ( F = 5.0, p = 0.008), but not city and pharmacy type ( F = 0.66, p = 0.62) or city and drug ( F = 0.27, p = 0.97). Average drug prices were lower at independent pharmacies compared with chain pharmacies for difluprednate (US$211.36 versus US$216.85, F = 1.09, p = 0.297) and significantly lower for loteprednol etabonate (US$255.49 versus US$274.86, F = 14.7, p Conclusions:Medication prices do not differ significantly between US cities. High variation of drug prices within the same city demonstrates how comparison shopping can provide cost savings for patients and may reduce cost-related nonadherence.

We aimed to evaluate the safety and efficacy of loteprednol etabonate (LE) gel 0.5% compared with vehicle in the treatment of postoperative inflammation and pain following cataract surgery, using the integrated analysis of data from two identical, prospective, multicenter, randomized, double-masked, parallel-group, vehicle-controlled trials.Patients with anterior chamber cell (ACC) inflammation ≥ grade 2 (6-15 cells) 1 day post-surgery were randomized to receive 1 or 2 drops of LE gel 0.5% or vehicle 4 times per day instilled in the study eye for 14 days. Primary outcome measures included the proportion of patients with complete resolution of ACC and grade 0 (no) pain on postoperative Day 8. Safety endpoints included adverse events (AEs), changes from baseline in intraocular pressure (IOP) and visual acuity (VA), biomicroscopy, and funduscopy findings. Gel comfort was graded by patients according to drop sensation.The intent-to-treat population included 813 patients (409 LE gel 0.5% and 404 vehicle). At postoperative Day 8, 30.8% and 15.1% of patients randomized to LE gel 0.5% or vehicle, respectively, had complete resolution of ACC, while 74.3% and 43.8% of patients, respectively, had grade 0 pain (P0.001 for both). Tolerability assessments for ocular itching, photophobia, and tearing favored LE gel 0.5% compared with vehicle at different time points beginning at Day 3. Two patients in the LE gel 0.5% group and 1 patient in the vehicle group exhibited a transient treatment-emergent increase in IOP ≥ 10 mmHg. Treatment-related AEs were generally mild to moderate and occurred less frequently with LE gel 0.5% than with vehicle. Reports of treatment-related blurred vision were rare (n = 2, vehicle).LE gel 0.5% was efficacious and well tolerated in the treatment of postoperative pain and inflammation following ocular surgery, with minimal risk of IOP elevation.

To evaluate the efficacy and safety of loteprednol etabonate (LE) 0.5 % in vernal keratoconjunctivitis (VKC) patients compared to prednisolone and fluorometholone.The patients were randomized into three groups: the loteprednol group, prednisolone group and fluorometholone group. Medications were administered four times daily, for a total of 28 days. Before starting treatment and at each visit thereafter, the major symptoms and signs of VKC were recorded and graded as 0 (none), 1 (mild), 2 (moderate) or 3 (severe). Adverse event reports including elevation of intraocular pressure (IOP) were recorded.There were no significant differences among the groups concerning baseline mean scores of signs and symptoms, which gradually improved in all except for pannus formation in the fluorometholone group. However, all signs and symptoms (except for chemosis) were significantly less improved in the eyes of the fluorometholone group compared with the other groups at each control visit. There was significant IOP elevation after the day 3 visit in the prednisolone group only.LE was as effective as prednisolone and more effective than fluorometholone, and it had no side effects during the short-term treatment of VKC patients.

Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension (LE/T) is indicated for steroid-responsive inflammatory ocular conditions where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. LE/T was shown to be safe in healthy volunteers and patients aged 18 years and older with minimal effect on intraocular pressure (IOP). The aim of the study was to evaluate the safety of LE/T in pediatric subjects by examining data from two clinical studies. Two randomized, multicenter, double-masked, parallel-group (one two-arm, the other four-arm) studies were conducted in subjects aged 0–6 years (N = 245). One study assessed LE/T compared with vehicle in the management of lid inflammation (n = 108) and the other compared LE/T with loteprednol etabonate ophthalmic suspension 0.5% (LE), tobramycin ophthalmic solution 0.3% (tobramycin), and vehicle in the treatment of blepharoconjunctivitis (n = 137). In the first study, subjects were randomized to LE/T or vehicle administered four times daily (qid) for the first 7 days followed by twice daily (bid) for 7 days along with warm compresses bid for the entire 2 weeks. In the second study, subjects were randomized to LE/T, LE, tobramycin, or vehicle administered qid for 14 days. Treatment-emergent ocular and non-ocular adverse events (AEs) and bilateral vision were assessed at all study visits in both studies. In addition, in the lid inflammation study, IOP was assessed at all visits. The primary safety endpoint in both studies was the incidence of treatment-emergent AEs. The incidence of LE/T treatment-emergent AEs was low. A total of four ocular AEs were reported for three LE/T-treated subjects in the first study (conjunctivitis [two events], meibomian gland dysfunction, and corneal staining), and one ocular AE was reported for an LE/T-treated subject in the second study (eye pain). A total of 13 non-ocular AEs were reported for eight LE/T-treated subjects in the two trials. The most prevalent non-ocular AEs were pyrexia (three events) and rash (two events). There were no differences in the incidence of specific ocular and non-ocular AEs between the LE/T group and the comparator treatment group. In both studies, there were no clinically meaningful reductions in vision at follow-up visits. Mean IOP and IOP changes from baseline, assessed in the lid inflammation study, were not different between LE/T and vehicle treatment groups at any study visits. The results of these two clinical trials demonstrate the short-term safety of treatment with topical LE/T in pediatric subjects (0–6 years of age) with lid inflammation or blepharoconjunctivitis.

Purpose The aim of this study was to present a case of a patient who showed a significant increase in intraocular pressure (IOP) with topical administration of loteprednol etabonate 0.2%. Case Report A 29-year-old man administered 1 drop of loteprednol etabonate 0.2% (Alrex ® ) to both eyes 4 times a day for 3 days as an off-label treatment for chronic red eye. By the third day of treatment, IOPs increased to 50 mmHg in each eye. The patient had no previous history of glaucoma. Gonioscopy found open angles in each eye. IOP returned to normal levels after discontinuation of Alrex. Steroid response in the same patient was confirmed on a second trial of Alrex. Conclusions Although loteprednol etabonate has been shown to have a minimal effect on IOP in most patients, close follow-up is necessary whenever therapy is initiated.