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John Hovanesian,1 Thomas Chester,2 Robert C Sorenson3 1Harvard Eye Associates, Laguna Hills, CA, USA; 2Cleveland Eye Clinic, Cleveland, OH, USA; 3Inland Eye Specialists, Hemet, CA, USACorrespondence: John Hovanesian, Harvard Eye Associates, 23961 Calle Magdalena, Suite 300, Laguna Hills, CA, 92653, USA, Tel +1 949 951 2020, Email jhovanesian@harvardeye.comPurpose: To examine the efficacy and tolerability of a combination of cyclosporine 0.1% and loteprednol 0.2% (CsA–LE; Klarity CL) in comparison to commercially available cyclosporine 0.05% (CsA; Restasis) in improving signs and symptoms of dry eye.Methods: This multicenter, prospective, randomized, controlled, open-label study evaluated 60 patients randomized to a single treatment for 4 weeks and evaluated at day 0, day 14, and day 28. Comparison was made of corneal higher-order aberrations (HOAs), dry-eye symptoms (SPEED score), tear-breakup time (TBUT), corneal staining, and ocular hyperemia, as well as tolerability of each medication with the validated COMTOL instrument.Results: A total of 56 patients completed enrollment. Corneal HOAs improved significantly with CsA–LE, but not CsA alone. Both groups showed significant improvement (with no significant differences between groups) in SPEED scores, corneal staining, TBUT, and conjunctival hyperemia. Tolerability was similar between the drugs, and no significant safety issues were identified.Conclusion: The combination of CsA 0.1%–LE 0.2% provided significant improvement in corneal HOAs, while CsA 0.05% did not. For all other measures of ocular surface improvement, both medications showed similar benefits. Tolerability was comparable between the formulations. When rapid rehabilitation of the ocular surface is needed to reduce aberrations, CsA–LE is an appropriate choice.Keywords: dry eye, higher-order aberrations, loteprednol, cyclosporine

Design of experiment (DOE) assisted simple, rapid, precise and accurate stability indicating HPLC method has been developed for simultaneous estimation of Gatifloxacin (GTF) and Loteprednol (LOT) along with their forced degradation products. The developed method has been optimized and developed by using central composite design (CCD) in response surface methodology (RSM). Trails have been undertaken and ratio of phosphate buffer in mobile phase, pH of buffer and flow rate are selected as factors. Resolution, tailing factor (GTF) and tailing factor (LOTE) are selected for determining the system response in the process of method optimization. The responses have been optimized using the Derringer's desirability function. The effective separation is achieved on Phenomenex EVO-C18 column (250 mm x 4.6 mm i.d, 5 μm particle size) with mobile composed of 10 mM phosphate buffer, pH 3.5 and organic phase composed of mixture of acetonitrile and methanol 60:40 % v/v, the flow rate was 1.0 mL/min, the signals were detected at 267 nm. The developed method was validated for linearity, accuracy, precision, and robustness. The method was applied successfully for stability samples. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To systematically review the efficacy and safety of loteprednol combined with sodium hyaluronate in the treatment of moderate-severe dry eye METHODS: Randomized controlled trials on loteprednol combined with sodium hyaluronate in the treatment of moderate-severe dry eye ( the research group was given loteprednol combined with sodium hyaluronate for eye-dropping, while the control group was given sodium hyaluronate alone) were retrieved from the Cochrane Library, PubMed, EMBase, CNKI, Wanfang database and CBM from basebuilding to Feb. 2021. After independently literature screening, information extracting and bias evaluation by two researchers, RevMan 5. 4 was adopted to conduct Meta-analysis. RESULTS: Totally 8 studies were involved, including 771 patients(1 416 eyes), of which 387 patients(710 eyes) were in the research group, and 384 patients(706 eyes) were in the control group. Results of Meta-analysis indicated that in terms of effectiveness, the total effective rate (OR = 3. 14,95%CI = 1. 81-5. 45,P<0. 000 1), score of dry eye symptom(MD = -9. 49,95%CI = -9. 94--9. 04,P<0. 000 01), breakup time of tear film ( BUT) at 2 weeks after treatment ( MD = 1. 92, 95% CI = 1. 72-2. 12, P < 0. 000 01), BUT at 4 weeks after treatment(MD = 3. 56,95%CI = 3. 22-3. 91,P<0. 000 01), BUT at 6 weeks after treatment(MD= 4. 40,95%CI = 3. 97-4. 83,P<0. 000 01), BUT at 8 weeks after treatment(MD= 5. 14,95%CI = 4. 81- 5. 48,P<0. 000 01), score of corneal fluorescein staining at 2 weeks after treatment(MD = -2. 27,95%CI = -2. 58- -1. 97,P<0. 000 01), score of corneal fluorescein staining at 6 weeks after treatment(MD = -2. 42,95%CI = -2. 77- -2. 06,P<0. 000 01), score of corneal fluorescein staining at 8 weeks after treatment(MD = -2. 67,95%CI = -2. 94- -2. 40,P<0. 000 01) and result of Schirmer test( Schirmer Ⅰ) (MD = 0. 20,95%CI = 0. 11-0. 29,P<0. 000 01) of research group were significantly higher those of the control group, with statistically significantly differences; in terms of safety, there was no statistical significance in the difference in incidences of adverse drug reactions between two groups(OR = 0. 76,95%CI = 0. 37-1. 57,P = 0. 46>0. 05). CONCLUSIONS: Present evidence shows that loteprednol combined with sodium hyaluronate is safe, effective and quickly effected in the treatment of moderate-severe dry eye, which has obvious advantages over sodium hyaluronate alone. The result evidence is limited by the quantity and quality of involved studies, and the above conclusions need to be verified by more high-quality studies. [ABSTRACT FROM AUTHOR]

AIM: To do a randomized prospective interventional study for comparing the effects of a single subconjunctival triamcinolone acetonide (SCTA) injection to tapering topical loteprednol in patients undergoing phacoemulsification surgery under topical anesthesia. METHODS: A total of 400 patients were randomized into 2 groups; Group A (200 patients) received 5 mg SCTA at the end of surgery and topical ketorolac tromethamine (0.5%) with ofloxacin (0.3%) combination for 3wk. Group B (200 patients) received tapering topical loteprednol etabonate (0.5%) along with ofloxacin (0.3%) and ketorolac tromethamine (0.5%) for 3wk. Outcomes evaluated were intraocular pressure (IOP), anterior chamber cells/flare and macular oedema postoperatively at 1, 6 and 12wk. RESULTS: Baseline parameters were almost similar in both the groups. No statistical difference was seen between the preoperative and postoperative IOP values for Group A (P=0.82) and Group B (P=0.61) and postoperative IOP values in between both groups (P=0.14) at 1wk. Incidence of cells/flare postoperative was statistically not significant (P=0.82) in both groups at all follow up visits. Postoperative macular oedema was not observed at any follow up visit. CONCLUSION: SCTA appears to be an effective alternative to prolong postoperative topical steroid use.

PURPOSE: The purpose of this study is to compare the efficacy of topical cyclosporine (Cs) 0.05% alone and topical Cs 0.05% with loteprednol 0.5% in patients with moderate dry eye. STUDY DESIGN: This was a comparative, prospective, interventional study. PATIENTS AND METHODS: A total of 140 patients diagnosed with moderate dry eyes were randomly divided into two groups. Group A patients received treatment with topical loteprednol 0.5% started as QID dosage for 2 weeks and tapered to BID dosage over the next 6 weeks, topical Cs 0.05% BID and artificial tears. Group B patients received treatment with topical Cs 0.05% BID and artificial tears. All patients were followed over a period of 6 months with ocular surface disease index (OSDI) questionnaire, tear film break up time (TBUT), corneal fluorescein, and lissamine green staining scores. RESULTS: There was a significant difference in the symptoms and signs of dry eye in the group receiving combination of loteprednol 0.5% and Cs 0.05% as compared to the group receiving Cs alone evident by greater reduction in OSDI score, corneal staining, and improvement in TBUT and Schirmer's test values over a follow-up of 6 months. CONCLUSION: Combination therapy with topical loteprednol and Cs is significantly better than topical Cs alone on alleviating symptoms and signs in moderate dry eye patients.

Mark D Mifflin,1 Brent S Betts,1 P Adam Frederick,2 Jason M Feuerman,3 Carlton R Fenzl,4 Majid Moshirfar,1,5 Brian Zaugg1 1Department of Ophthalmology and Visual Sciences, John A Moran Eye Center, University of Utah, Salt Lake City, UT, 2The Eye Center, Huntsville, AL, 3Eye Institute of Austin, Austin, TX, 4Eye Surgeons Associates, Bettendorf, IA, 5Hoopes Vision, Draper, UT, USA Purpose: To compare the outcome of photorefractive keratectomy (PRK) and complications in patients treated with either loteprednol etabonate 0.5% gel or prednisolone acetate 1% suspension and fluorometholone (fml) 0.1% suspension.Setting: John A Moran Eye Center, University of Utah, Salt Lake City, UT, USA.Design: Prospective, randomized, partially masked trial.Methods: PRK was performed on 261 eyes of 132 participants. Patients were randomized to a postoperative corticosteroid regimen of either loteprednol etabonate 0.5% gel (loteprednol) or prednisolone 1% acetate suspension followed by fluorometholone 0.1% suspension (prednisolone/fml). Primary outcome measures included incidence and grade of postoperative corneal haze and incidence of increased intraocular pressure of 10 mmHg above baseline, or any intraocular pressure over 21 mmHg. Secondary outcome measures included uncorrected distance visual acuity, best corrected distance visual acuity, and manifest refraction spherical equivalent.Results: The incidence of haze in the first 3 months was 2.6% (3/114 eyes) in the loteprednol group and 4.8% (7/147 eyes) in the prednisolone/fml group and was not statistically significant between groups (P=0.37). The incidence of elevated intraocular pressure was 1.8% (2/114 eyes) in the loteprednol group and 4.1% (6/147 eyes) in the prednisolone/fml group, and was not statistically significant between the groups (P=0.12). The mean 3-month postoperative logMAR uncorrected visual acuity was −0.078±0.10 and −0.075±0.09 in the loteprednol and prednisolone/fml groups, respectively (P=0.83).Conclusion: Postoperative corneal haze and elevated intraocular pressure were uncommon in both treatment arms. There was no statistically significant difference between each postoperative regimen. Refractive results were similar and excellent in both treatment arms. A tapered prophylactic regimen of loteprednol 0.5% gel is equally effective to prednisolone 1%/fml 0.1% after PRK. Keywords: PRK, corticosteroid, fluorometholone, loteprednol, lotemax, wavefront optimized

Purpose: To compare the efficacy and side effects of loteprednol versus fluorometholone after myopic photorefractive keratectomy (PRK). Methods: One hundred and twenty four eyes of 62 patients who underwent PRK were enrolled in this study. One eye of each subject was randomized to receive loteprednol 0.5% and the fellow eye was given fluorometholone 0.1%. Patients were followed up for three months. Results: There was no significant difference in uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction, corneal haze, intraocular pressure (IOP), and ocular discomfort and redness between groups at the final visit. At 3 months postoperatively, 20/25 or better UDVA was achieved in 95% of the loteprednol group and 92% of the fluorometholone group (P > 0.05). There was neither visually significant corneal haze nor ocular hypertension (IOP rise > 10 mmHg or IOP > 21 mmHg) in any group. Conclusion: The efficacy and side effects of loteprednol 0.5% and fluorometholone 0.1% after myopic PRK are comparable.

PURPOSE: The purpose of this study is to compare the efficacy of topical cyclosporine (Cs) 0.05% alone and topical Cs 0.05% with loteprednol 0.5% in patients with moderate dry eye. STUDY DESIGN: This was a comparative, prospective, interventional study. PATIENTS AND METHODS: A total of 140 patients diagnosed with moderate dry eyes were randomly divided into two groups. Group A patients received treatment with topical loteprednol 0.5% started as QID dosage for 2 weeks and tapered to BID dosage over the next 6 weeks, topical Cs 0.05% BID and artificial tears. Group B patients received treatment with topical Cs 0.05% BID and artificial tears. All patients were followed over a period of 6 months with ocular surface disease index (OSDI) questionnaire, tear film break up time (TBUT), corneal fluorescein, and lissamine green staining scores. RESULTS: There was a significant difference in the symptoms and signs of dry eye in the group receiving combination of loteprednol 0.5% and Cs 0.05% as compared to the group receiving Cs alone evident by greater reduction in OSDI score, corneal staining, and improvement in TBUT and Schirmer's test values over a follow-up of 6 months. CONCLUSION: Combination therapy with topical loteprednol and Cs is significantly better than topical Cs alone on alleviating symptoms and signs in moderate dry eye patients. [ABSTRACT FROM AUTHOR]

Purpose: To compare the effects of topical loteprednol and fluorometholone in children who underwent strabismus surgery.Methods: 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.Results: 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 IOP >21 mmHg. There was no significant difference between the 2 groups in patient discomfort, conjunctival inflammation, and conjunctival injection.Conclusions: 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. [ABSTRACT FROM AUTHOR]

Purpose: To compare the effects of topical loteprednol and fluorometholone in children who underwent strabismus surgery. Methods: 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. Results: 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 IOP >21 mmHg. There was no significant difference between the 2 groups in patient discomfort, conjunctival inflammation, and conjunctival injection. Conclusions: 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. [ABSTRACT FROM AUTHOR]