Abstract | PURPOSE: DESIGN: Randomized, double-masked, vehicle-controlled or active-controlled, multicenter, clinical trials. PARTICIPANTS AND CONTROLS: A total of 872 subjects (872 study eyes: bromfenac in 584, placebo in 288). METHODS: Four randomized, double-masked, vehicle or active-controlled, clinical trials were conducted at 134 ophthalmology clinics in the United States. Subjects aged ≥ 18 years were randomized to receive either bromfenac 0.09% or placebo dosed once daily beginning 1 day before cataract surgery (day -1), continuing on the day of surgery (day 0), and continuing for an additional postoperative 14 days. Subjects were evaluated for efficacy and safety on days 1, 3, 8, 15, and 22. The primary efficacy end point was cleared ocular inflammation, measured by the summed ocular inflammation score (SOIS; anterior chamber cells and flare) by day 15. The secondary efficacy end point was the number of subjects who were pain-free at day 1. The data from the 4 trials were pooled for analyses. MAIN OUTCOME MEASURES: The SOIS and ocular pain. RESULTS: The proportion of subjects who had cleared ocular inflammation by day 15 was significantly higher in the bromfenac 0.09% group than in the placebo group (P < 0.0001). The mean SOIS in the bromfenac 0.09% group was significantly lower than in the placebo group at days 3, 8, 15, and 22 (P < 0.0001). The proportion of subjects who were pain-free at days 1, 3, 8, and 15 was significantly higher in the bromfenac 0.09% group than in the placebo group (P < 0.0001). The incidence of adverse events reported in the bromfenac 0.09% group was significantly lower than in the placebo group (P < 0.0001). On day 15, 84.0% of the bromfenac subjects had ≥ 1-line improvement in visual acuity compared with 66.1% of placebo subjects (P < 0.0001). CONCLUSIONS: FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
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Authors | Bonnie A Henderson, Johnny L Gayton, Simon P Chandler, James A Gow, Sharon M Klier, Timothy R McNamara, Bromfenac Ophthalmic Solution (Bromday) Once Daily Study Group |
Journal | Ophthalmology
(Ophthalmology)
Vol. 118
Issue 11
Pg. 2120-7
(Nov 2011)
ISSN: 1549-4713 [Electronic] United States |
PMID | 21762992
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Benzophenones
- Bromobenzenes
- Ophthalmic Solutions
- bromfenac
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Topics |
- Aged
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage, adverse effects)
- Benzophenones
(administration & dosage, adverse effects)
- Bromobenzenes
(administration & dosage, adverse effects)
- Cataract Extraction
- Double-Blind Method
- Endpoint Determination
- Eye Pain
(drug therapy, physiopathology)
- Female
- Humans
- Inflammation
(drug therapy, physiopathology)
- Lens Implantation, Intraocular
- Male
- Ophthalmic Solutions
(administration & dosage, adverse effects)
- Pain, Postoperative
(drug therapy)
- Postoperative Complications
- Pseudophakia
(physiopathology)
- Treatment Outcome
- Uveitis, Anterior
(drug therapy, physiopathology)
- Visual Acuity
(physiology)
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