Search

Purpose: To compare patient-reported tolerability, impact on quality of life, interference with activities of daily life, and ocular surface toxicity of branded nepafenac 0.3% and generic ketorolac 0.5% after cataract surgery., Setting: Harvard Eye Associates, Laguna Hills, California, and the Cincinnati Eye Institute, Ohio, USA., Design: Prospective case series., Methods: One eye of each patient was randomized to receive ketorolac 0.5% or nepafenac 0.3% topical eyedrops for 3 days preoperatively and 28 days postoperatively. Additional medications were moxifloxacin 0.5% 4 times a day 3 days preoperatively and 7 days postoperatively and difluprednate 0.05% twice a day for 1 week postoperatively. Primary endpoints were patient-reported tolerability of each drug, the related impact on quality of life, and activities of daily life. Secondary endpoints were differences in conjunctival hyperemia, anterior chamber inflammation, tear breakup time (TBUT), and corneal staining., Results: Baseline characteristics were similar between the nepafenac group (n = 91) and the ketorolac group (n = 90). Burning and stinging lasted longer in the ketorolac group, while blurry/hazy/foggy vision and a film or coating on the eye lasted longer in the nepafenac group (all P < .0001). All objective measures were statistically significant for ketorolac 0.5% versus nepafenac 0.3% as follows: corneal staining (64% versus 28%); Oxford grade 2 or greater staining (28% versus 4%); Schulze grade 30 or greater conjunctival erythema (65% versus 36%, respectively); abnormal TBUT greater than 10 seconds (77% versus 51%) (all P < .0001)., Conclusion: Branded nepafenac 0.3%-treated patients had significantly better objective and subjective outcomes after cataract surgery than generic ketorolac 0.5%-treated patients., (Copyright © 2018 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare the antiinflammatory efficacy of topical nepafenac 0.3% for prophylaxis of macular edema after cataract extraction., Setting: São Paulo University, São Paulo, Brazil., Design: Prospective randomized clinical trial., Methods: Patients with bilateral cataract were included in this study. Each patient was assigned randomly to receive nepafenac 0.3% drops in 1 eye and a placebo in the fellow eye. The primary outcome measure was the change in the mean spectral-domain optical coherence tomography central subfield thickness 5 weeks postoperatively. The secondary outcome measures were the total macular volume 1, 5, and 12 weeks postoperatively; the percentage of patients in both groups who developed macular edema, and the corrected distance visual acuity within 5 weeks and 12 weeks after cataract surgery., Results: The study comprised 224 eyes of 112 patients. For all retinal thickness measurements, a significant increase in both groups was detected starting from the first postoperative week until 12 weeks. At 5 weeks, there was a statistically significant difference in central subfield thickness and total macular volume between the nepafenac group and control group (P = .01 and P < .001, respectively). At the fifth postoperative week, no eye in the nepafenac group and 4 eyes (3.57%) in the control group had macula edema, highlighting a trend toward a greater incidence in the control group. The between-group differences in visual outcomes were not statistically significant., Conclusion: Used prophylactically after cataract surgery, nepafenac 0.3% was efficacious in reducing macular thickness compared with a placebo 5 weeks postoperatively, without a difference in final visual acuity., (Copyright © 2018 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To study the effect of topical ketorolac 0.4% (Acular LS), bromfenac 0.09% (Megabrom), and nepafenac 0.1% (Nevanac) on postoperative inflammation using laser flare photometry in patients having phacoemulsification with posterior chamber intraocular lens (PC IOL) implantation., Setting: Tertiary care center, Chandigarh, India., Design: Prospective randomized case series., Methods: Patients with age-related cataract having phacoemulsification with PC IOL implantation were randomized into 4 groups receiving topical ketorolac 0.4% (Group A), bromfenac 0.09% (Group B), nepafenac 0.1% (Group C), or no nonsteroidal antiinflammatory drugs (NSAIDs) (Group D, control). The topical NSAIDs were started 1 day prior to the surgery and continued for 6 weeks postoperatively. All patients received a standard regimen of moxifloxacin 0.5% (Vigamox) and prednisolone acetate 1.0% (Pred Forte) eyedrops in tapering doses postoperatively. Visual acuity, intraocular pressure (IOP), laser flare photometry, and fundus examination were done preoperatively and postoperatively at 1 day and 1, 2, 4, and 8 weeks., Results: The study comprised 120 patients (120 eyes) (Group A = 33 patients, Group B = 30 patients, Group C = 31 patients, and Group D = 26 patients). The laser flare photometry values at the end of 4 weeks and 8 weeks were minimal in the nepafenac group compared with the other NSAID groups and the no-NSAID group (P = .032 at 4 weeks and P = .252 at 8 weeks)., Conclusions: The topical NSAIDs ketorolac 0.4%, bromfenac 0.09%, and nepafenac 0.1% were effective for the reduction of postoperative inflammation following phacoemulsification. Compared with ketorolac tromethamine, bromfenac, and the control, nepafenac was significantly effective 1 month postoperatively in reducing anterior chamber flare, as evidenced by decreased laser flare photometry., Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned., (Copyright © 2015 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the efficacy of adding nepafenac 0.1% ophthalmic suspension to dexamethasone 0.1% eyedrops in controlling macular swelling and other manifestations of inflammation after uneventful cataract surgery., Setting: Ophthalmology Department, Mölndal Hospital, Gothenburg, and St. Erik Eye Hospital, Stockholm, Sweden., Design: Randomized double-masked clinical trial., Methods: Patients at low risk for postoperative inflammation were recruited and randomized to the nepafenac group or to the control group. Postoperative swelling of the macula was assessed with ocular coherence tomography. Laser flare intensity, corrected distance visual acuity, ocular discomfort, and visual complaints were also recorded., Results: The analysis of intent-to-treat population comprised 75 patients in the nepafenac group and 77 patients in the control group. Compared with the control regimen, add-on nepafenac resulted in statistically significant reductions in the following parameters: change in macular volume at 3 weeks and 6 weeks (P<.001), proportion of patients with more than 10 μm of swelling in the central macula at 3 weeks (P<.0001) and 6 weeks (P=.02), mean laser flare intensity at 1 day (P=.029), pain during the first 24 hours postoperatively (P<.0001), and ocular discomfort and photophobia during the first 3 postoperative weeks (P=.0058 and P=.0052, respectively)., Conclusion: The combination of topical nepafenac and steroid treatment reduced subclinical macular swelling and inflammation as well as subjective complaints, indicating it is an efficient antiinflammatory regimen after cataract surgery., Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned., (Copyright © 2014 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate once-daily nepafenac 0.3% to prevent and treat ocular pain and inflammation after cataract surgery., Setting: Sixty-five centers in the United States and Europe., Design: Randomized double-masked vehicle- and active-controlled phase 3 study., Methods: Patients received nepafenac 0.3% once daily, nepafenac 0.1% 3 times daily, or their respective vehicles from day -1 to day 14 after cataract extraction. An additional drop of study drug was administered 30 to 120 minutes preoperatively. The primary endpoint was the percentage of patients with a cure for inflammation (score of 0 for both aqueous cells and flare) at day 14., Results: Of randomized patients, 817 received nepafenac 0.3%, 819 received nepafenac 0.1%, and 200 and 206 received the respective vehicles. Significantly more nepafenac 0.3% patients had no inflammation (68.4% versus 34.0%) and were pain free (91.0% versus 49.7%) at day 14 than vehicle patients (both P<.0001). Nepafenac 0.3% was noninferior to nepafenac 0.1% for inflammation (95% confidence interval [CI], -5.73% to 3.17%) and pain-free rates (95% CI, -3.08% to 2.70%). At all postoperative visits, fewer treatment failures (P≤.0012) and more clinical successes (P ≤ .0264) were observed with nepafenac 0.3% versus vehicle. Nepafenac 0.3% was well tolerated and had a safety profile comparable to that of nepafenac 0.1%., Conclusions: Once-daily nepafenac 0.3% was noninferior to nepafenac 0.1% 3 times daily for prevention and treatment of ocular inflammation and pain following cataract surgery. The safety of nepafenac 0.3% was comparable to that of nepafenac 0.1%, with the added convenience of once-daily dosing., Financial Disclosure: Drs. Modi, Lehmann, Walters, Fong, Christie, Roel, Nethery, and Reiser have been paid consultants to Alcon Research, Ltd. Ms. Sager is an employee of Alcon Research, Ltd. Drs. Tsorbatzoglou, Philipson, and Traverso have no financial or proprietary interest in any material or method mentioned., (Copyright © 2013 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the efficacy of prophylactic ketorolac 0.5% versus nepafenac 0.1% versus placebo on macular volume 1 month after uneventful phacoemulsification and evaluate the health-related quality-of-life (HRQOL) of topical nonsteroidal antiinflammatory drugs (NSAIDs) in the context of cataract surgery., Setting: Hotel Dieu Hospital, Kingston, Ontario, Canada., Design: Prospective placebo-controlled parallel-assignment double-masked randomized clinical trial., Methods: In this study, patients 18 years or older scheduled for routine phacoemulsification were randomized to a placebo, ketorolac 0.5%, or nepafenac 0.1% and dosed 4 times a day starting 1 day before surgery and continuing for 4 weeks. Spectral-domain macular cube ocular coherence tomography scans measuring central subfield thickness, macular cube volume, and average macular cube thickness were performed at baseline and 1 month postoperatively. The HRQOL metrics were determined with the Comparison of Ophthalmic Medications for Tolerability (COMTOL) questionnaire., Results: Each study group comprised 54 patients. One month postoperatively, although a trend toward significance occurred for nepafenac and ketorolac, analysis of the means of differences showed no statistically significant differences between the 3 study groups (P=.2901). The COMTOL analysis found no difference in tolerability, compliance, side-effect frequency and bother, and effects on HRQOL between ketorolac and nepafenac compared with the placebo., Conclusions: One month after uneventful phacoemulsification, there was no difference in macular volume between the placebo, ketorolac, and nepafenac. Ketorolac and nepafenac were well tolerated with minimal side-effect profiles. Thus, for patients without risk factors having routine surgery, prophylactic topical NSAIDs are not recommended., (Copyright © 2012 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare a topical nonsteroidal antiinflammatory drug (nepafenac 0.1%) and a topical steroidal antiinflammatory drug (fluorometholone 0.1% ) in preventing cystoid macular edema (CME) and blood-aqueous barrier (BAB) disruption after small-incision cataract extraction with foldable intraocular lens (IOL) implantation., Setting: Shohzankai Medical Foundation, Miyake Eye Hospital, Nagoya, Japan., Design: Randomized double-masked single-center clinical trial., Methods: Patients were randomized to receive nepafenac 0.1% eyedrops or fluorometholone 0.1% eyedrops for 5 weeks after phacoemulsification with foldable IOL implantation. The incidence and severity of CME were evaluated by fluorescein angiography, retinal foveal thickness on optical coherence tomography, and BAB disruption on laser flare-cell photometry., Results: Thirty patients received nepafenac and 29 patients, fluorometholone. Five weeks postoperatively, the incidence of fluorescein angiographic CME was significantly lower in the nepafenac group (14.3%) than in the fluorometholone group (81.5%) (P<.0001). The fovea was thinner in the nepafenac group than in the fluorometholone group at 2 weeks (P=.0266) and 5 weeks (P=.0055). At 1, 2, and 5 weeks, anterior chamber flare was significantly less in the nepafenac group than in the fluorometholone group (P<.0001, P<.0001, and P=.0304, respectively). The visual acuity recovery from baseline was significantly greater in the nepafenac group (80.0%) than in the fluorometholone group (55.2%) (P=.0395). There were no serious side effects in either group., Conclusion: Nepafenac was more effective than fluorometholone in preventing angiographic CME and BAB disruption, and results indicate nepafenac leads to more rapid visual recovery., (Copyright © 2011 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare the effectiveness of nepafenac 0.10% in achieving and maintaining pupil dilation with the effectiveness of flurbiprofen 0.03% and a placebo in a rabbit model., Setting: Department of Ophthalmology, University of California, San Francisco, California, USA., Design: Laboratory study., Methods: Adult pigmented rabbits were randomized to 3 equal-sized groups: placebo, flurbiprofen, and nepafenac. Cataract surgery was performed in randomized order by a surgeon who was masked to group assignment. The treatment or placebo was administered starting 1 day before surgery. Phenylephrine 10.0% was administered starting 30 minutes before surgery. Phacoemulsification was performed in standard fashion. Pupil measurements were recorded before and after surgery. A linear mixed model with a random effect for the rabbits and a fixed effect for the treatment groups was used to compare mean pupil diameters between groups., Results: Baseline pupil measurements were similar between the placebo, flurbiprofen, and nepafenac groups. Preoperative pupil dilation was statistically significantly greater in the nepafenac group (mean 11.5 mm ± 0.5 [SD]) than in the placebo group (mean 10.2 ± 1.1 mm) and the flurbiprofen group (mean 9.9 ± 1.1 mm) (P<.005 and P<.001, respectively). The greater dilation was maintained at the end of surgery, at which time the nepafenac group had statistically significantly larger pupils (mean 9.4 ± 1.2 mm) than the placebo group (mean 7.9 ± 0.6 mm) and the flurbiprofen group (mean 8.5 ± 0.9 mm) (P<.001 and P<.05, respectively)., Conclusion: Nepafenac was more effective than a placebo and flurbiprofen in achieving maximum preoperative and postoperative pupil mydriasis in rabbits., (Copyright © 2010 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)

Purpose: To assess delayed epithelialization and corneal haze related to nepafenac ophthalmic suspension 0.1% (Nevanac) use after photorefractive keratectomy (PRK)., Setting: Private practice, Beverly Hills, California, USA., Methods: This retrospective comparative chart review comprised 69 eyes (44 patients) that were divided into 2 treatment groups that were not statistically significantly different in age or preoperative spherical equivalent. The nepafenac group consisted of 34 eyes (22 patients) that received nepafenac 0.1%, moxifloxacin, and fluorometholone postoperatively. The non-nepafenac group included 35 eyes (22 patients) that received moxifloxacin and fluorometholone only. Patients were seen between 1 day and 5 days postoperatively for evaluation of epithelial healing and haze formation. Delayed epithelialization was defined as healing after day 5. All patients were followed for haze formation for a minimum of 3 months., Results: Statistical analysis showed no difference between the nepafenac and non-nepafenac groups in delayed epithelialization (P = .61, chi-square test). Neither group had significant corneal haze., Conclusion: Nepafenac did not appear to delay corneal epithelial healing or contribute to haze formation after PRK.

Purpose: To compare the clinical, subjective, and objective outcomes of the use of 2 topical nonsteroidal antiinflammatory drugs--ketorolac tromethamine LS 0.4% (Acular) and nepafenac 0.1% (Nevanac)--in patients having cataract surgery., Setting: Single-center private practice, Las Vegas, Nevada, USA., Methods: One hundred eighty-three patients (193 eyes) with visually significant cataract were recruited for the study. Consenting patients were randomized to a standard regimen of Acular, gatifloxacin 0.3% (Zymar), and prednisolone acetate 1% (Pred Forte) (ketorolac group) or Nevanac, moxifloxacin hydrochloride 0.5% (Vigamox), and prednisolone acetate (Econopred) (nepafenac group). Analysis included subjective complaints (burning, itching, foreign-body sensation, pain level after surgery) and objective findings (visual function, degree of inflammation in the anterior segment, complications)., Results: The ketorolac group consisted of 94 patients (100 eyes) and the nepafenac group, 89 patients (93 eyes). The between-group differences in visual outcomes and anterior chamber inflammation were not statistically significant (mean P = .33). There was a higher incidence of posterior capsule opacification in the nepafenac group (P = 0.019). Patient satisfaction, patient compliance, and postoperative pain control were statistically significantly better in the ketorolac group (P = .022, P = .023, and P = .025, respectively)., Conclusion: Ketorolac tromethamine was statistically significantly better than nepafenac in terms of patient satisfaction, compliance, and postoperative pain control.

Purpose: To determine whether nepafenac ophthalmic suspension 0.1% decreases the incidence and severity of inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation., Setting: Twenty-one ophthalmology clinics in the United States., Methods: A randomized double-blind vehicle-controlled trial was conducted in which adult patients were randomly assigned to receive nepafenac 0.1% or vehicle beginning 1 day before surgery and continuing on the day of surgery (day 0) for 14 days. Patients were evaluated on days 1, 3, 7, and 14. The primary efficacy variable was the percentage of patients cured at day 14 (cure defined as aqueous cells score + aqueous flare score = 0). Other efficacy variables included percentage of patients who were pain free at all visits and aqueous cells, flare, and cells plus flare scores., Results: The mean age of the 476 patients (243 nepafenac, 233 vehicle) was 70 years (range 27 to 93 years). At day 14, 152 patients (62.6%) in the nepafenac group and 40 (17.2%) in the vehicle group were cured (P<.0001). A higher percentage of patients in the nepafenac group was pain free at all visits (P<.0001). Throughout the study, most nepafenac-treated patients were pain free (83.1% to 93.0%) compared with less than half the vehicle-treated patients (41.6% to 46.4%). The nepafenac group had lower mean aqueous cells, flare, and cells plus flare scores at all visits (P<.0001). No treatment-related ocular adverse events occurred in either group., Conclusion: Nepafenac ophthalmic suspension 0.1% was safe and effective for preventing and treating ocular inflammation and pain associated with cataract surgery.