Bromfenac ophthalmic solution 0.09% (Xibrom) for postoperative ocular pain and inflammation.
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).


METHODS
Two phase III, multicenter, randomized, double-masked, parallel, placebo-controlled clinical trials were conducted under a common protocol. Data were pooled for analyses.


METHODS
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).


METHODS
Subjects who underwent cataract surgery without prior antiinflammatory treatment with a postsurgical Summed Ocular Inflammation Score (SOIS) of > or =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.


METHODS
Cleared ocular inflammation with a SOIS of 0 (cells< or =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.
Donnenfeld
Eric D
ED
External Disease/Cornea Department, Manhattan Eye, Ear and Throat Hospital, New York, New York, USA. eddoph@aol.com
Holland
Edward J
EJ
Stewart
Robert H
RH
Gow
James A
JA
Grillone
Lisa R
LR
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D001577:Benzophenones / Q000008:administration & dosage* / Q000009:adverse effects; D001969:Bromobenzenes / Q000008:administration & dosage* / Q000009:adverse effects; D002387:Cataract Extraction; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007249:Inflammation / Q000517:prevention & control; D007429:Intraocular Pressure / Q000187:drug effects; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects; D010149:Postoperative Pain / Q000188:drug therapy*; D016896:Treatment Outcome; D014606:Uveitis, Anterior / Q000188:drug therapy*; D014792:Visual Acuity / Q000187:drug effects
D000894:Anti-Inflammatory Agents, Non-Steroidal; D001577:Benzophenones; D001969:Bromobenzenes; D009883:Ophthalmic Solutions; C053083:bromfenac