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Bromfenac ophthalmic solution 0.07% dosed once daily for cataract surgery: results of 2 randomized controlled trials.
- Source :
-
Ophthalmology [Ophthalmology] 2014 Jan; Vol. 121 (1), pp. 25-33. Date of Electronic Publication: 2013 Sep 08. - Publication Year :
- 2014
-
Abstract
- Purpose: To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution 0.07% (Prolensa) dosed once daily for the treatment of ocular inflammation and pain in subjects who underwent cataract surgery with posterior chamber intraocular lens implantation.<br />Design: Two phase 3, randomized, double-masked, placebo-controlled, multicenter clinical trials.<br />Participants: Four hundred forty subjects (440 study eyes: 222 in the bromfenac group and 218 in the placebo group).<br />Methods: Two phase 3, prospective, randomized, double-masked, placebo-controlled clinical trials were conducted at 39 ophthalmology clinics in the United States. Subjects 18 years of age or older were randomized to receive either bromfenac 0.07% or placebo dosed once daily beginning 1 day before cataract surgery, on the day of surgery, and continuing for 14 days after surgery (for a total of 16 days). Subjects were evaluated on days 1, 3, 8, 15, and 22 after surgery. The primary efficacy end point was cleared ocular inflammation, as measured by the summed ocular inflammation score of zero (anterior chamber cell count = 0 and absence of flare) by day 15. Secondary end points included cleared ocular inflammation at day 15 and the number of subjects who were pain free at day 1. The data from the 2 clinical trials were integrated for analyses.<br />Main Outcome Measures: Summed ocular inflammation score and ocular pain.<br />Results: A significantly higher proportion of subjects treated with bromfenac 0.07% achieved complete clearance of ocular inflammation by day 15 and at day 15 compared with placebo (P < 0.0001). A statistically significantly higher proportion of subjects in the bromfenac 0.07% group were pain free at all study visits compared with those in the placebo group (P < 0.0001). Fewer subjects in the bromfenac group (3.2%) discontinued investigational product early because of a lack of efficacy than in the placebo group (23.9%; P < 0.0001). The incidence of adverse events was significantly lower in the bromfenac 0.07% group compared with the placebo group (P = 0.0041).<br />Conclusions: Bromfenac ophthalmic solution 0.07% dosed once daily was clinically safe and effective compared with placebo for the treatment of ocular inflammation and pain in subjects who had undergone cataract surgery and may be a beneficial addition to the current standard of care, which commonly includes ophthalmic antibiotics and corticosteroids.<br /> (Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Administration, Topical
Aged
Anti-Inflammatory Agents, Non-Steroidal adverse effects
Benzophenones adverse effects
Bromobenzenes adverse effects
Double-Blind Method
Eye Pain drug therapy
Female
Humans
Inflammation drug therapy
Male
Ophthalmic Solutions
Postoperative Care methods
Prospective Studies
Treatment Outcome
Uveitis drug therapy
Anti-Inflammatory Agents, Non-Steroidal administration & dosage
Benzophenones administration & dosage
Bromobenzenes administration & dosage
Lens Implantation, Intraocular
Phacoemulsification
Subjects
Details
- Language :
- English
- ISSN :
- 1549-4713
- Volume :
- 121
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Ophthalmology
- Publication Type :
- Academic Journal
- Accession number :
- 24021896
- Full Text :
- https://doi.org/10.1016/j.ophtha.2013.07.006