Bromfenac Ophthalmic Solution 0.09% (Xibrom) for Postoperative Ocular Pain and Inflammation
Data were presented in part at: American Academy of Ophthalmology 108th Annual Meeting, October 2004, New Orleans, Louisiana; American Society for Cataract and Refractive Surgery Symposium on Cataract, IOL, and Refractive Surgery, April 2005, Washington, DC; Association for Research in Vision and Ophthalmology (ARVO) annual meeting, May 2005, Fort Lauderdale, Florida; and ARVO annual meeting, May 2006, Fort Lauderdale, Florida.
Received 18 July 2006; received in revised form 21 December 2006; accepted 21 December 2006. published online 19 April 2007.
Objective
To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution 0.09% (Xibrom) for the treatment of postoperative inflammation and reduction of ocular pain in subjects who have undergone cataract extraction (CE).
Design
Two phase III, multicenter, randomized, double-masked, parallel, placebo-controlled clinical trials were conducted under a common protocol. Data were pooled for analyses.
Participants
Five hundred twenty-seven subjects were sequentially assigned, according to a computer-generated randomization list (2:1), to bromfenac (n = 356) or a placebo (n = 171).
Intervention
Subjects who underwent cataract surgery without prior antiinflammatory treatment with a postsurgical Summed Ocular Inflammation Score (SOIS) of ≥3 were treated with either bromfenac or the placebo, instilled twice daily for 14 days in the study eye, and observed for an additional 14 days for safety evaluation.
Main Outcome Measure
Cleared ocular inflammation with a SOIS of 0 (cells≤5 and absence of flare after 14 days of treatment). Secondary outcomes included time to resolution of ocular inflammation, time to resolution of ocular pain, proportion of subjects with photophobia, and ocular adverse events.
Results
Baseline characteristics were comparable between groups for age, gender, and race. The baseline mean SOIS was 3.7 in both groups. A greater proportion of bromfenac (64.0%) than placebo subjects (43.3%) achieved complete clearance of ocular inflammation at study day 15 (P<0.0001). The effect of bromfenac on clearance of ocular inflammation was as early as study day 3 after initiation of treatment, compared with the placebo (8.4% vs. 1.2%, P = 0.0012). The median time to resolution of ocular pain was 2 days (bromfenac) versus 5 days (placebo) (P<0.0001). Numbers of most ocular adverse events were lower for the bromfenac group than for the placebo group. Eye irritation was reported in a lower percentage of subjects for bromfenac (2.5%) versus placebo (4.7%), as were burning and stinging (1.4% vs. 2.5%), and photophobia (2.0% vs. 11.1%).
Conclusions
Bromfenac ophthalmic solution 0.09% effectively and rapidly cleared ocular inflammation and reduced ocular pain after CE. There were no serious ocular adverse events, and fewer adverse events were reported for the bromfenac group.
Available online: April 19, 2007.
1External Disease/Cornea Department, Manhattan Eye, Ear and Throat Hospital, New York, New York.
2Department of Ophthalmology, University of Cincinnati, Cincinnati, Ohio.
3Houston Eye Associates, Conner Glaucoma Center, Houston, Texas.
ABSTRACT