The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery

Abstract

Purpose

To evaluate the efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace (0–5 cells) anterior chamber cells, following cataract surgery with posterior chamber intraocular lens implantation.

Methods

The study designed employed two Phase III, double-masked, placebo-controlled, multicenter clinical trials of 440 subjects, randomized to either bromfenac ophthalmic solution 0.07% (n=222) or placebo (n=218). Subjects self-dosed once daily, beginning 1 day before undergoing cataract surgery with intraocular lens implantation (day –1) and again on the day of surgery (day 0) and for 14 days postoperatively. Follow-up was on days 1, 3, 8, and 15. The outcome measures included the percentage of subjects with zero-to-trace anterior chamber cells at each visit, as determined by the percentage of subjects with ≤5 anterior chamber cells, overall anterior chamber cell grades, and summed ocular inflammation score (SOIS) (combined anterior chamber cell and flare scores).

Results

The proportion of subjects with zero-to-trace anterior chamber cells was significantly higher in the bromfenac 0.07% group compared with the placebo group as early as day 3 (P=0.0007), continued at day 8 (P<0.0001), and through day 15 (P<0.0001). At day 15, 80.2% of subjects in the bromfenac 0.07% group achieved zero-to-trace anterior chamber cells compared with 47.2% of subjects who did so in the placebo group. The overall anterior chamber cell scores were significantly lower in the bromfenac 0.07% group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). The SOIS were also significantly lower in the bromfenac group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit).

Conclusion

Bromfenac ophthalmic solution 0.07%, dosed once daily was clinically effective in achieving zero-to-trace anterior chamber cell severity after cataract surgery and was superior to placebo in all anterior chamber cell severity and inflammation outcome measures.

Keywords:

• ocular inflammation
• anterior chamber inflammation
• non-steroidal anti-inflammatory
• cells and flare

Acknowledgments

The authors thank Sharon M Klier, MD, for contributions to the protocol conception and design, and data acquisition; and Michelle Dalton, BS, ELS, for medical writing assistance. These clinical trials were supported by Bausch + Lomb.

The Bromfenac Ophthalmic Solution 0.07% Once Daily Study Group members were:

S00124-WR; Jason Bacharach, MD; Donald Beahm, MD; James Boyce, MD; E Randy Craven, MD; Jung Dao, MD; Michael Depenbusch, MD; Eran Duzman, MD; Joseph Gira, MD; Damien Goldberg, MD; Kerry Hagen, MD; Michael Korenfeld, MD; Ryan McKinnon, MD; Karl Olsen, MD; James Peace, MD; Kenneth Sall, MD; David L Schwartz, MD; Steven Silverstein, MD; Robert Smyth-Medina, MD; Jon-Marc Weston, MD.

S00124-ER; Mark Bergmann, MD; Robert Berry, MD; Leonard Cacioppo, MD; David Cooke, MD; Thomas Elmer, MD; William Flynn, MD; Ronald Frenkel, MD; Marvin Greenberg, MD; Brennan Greene, MD; Mitchell Jackson, MD; Lawrence Katzen, MD; John Lim, MD; Parag Majmudar, MD; Bernard Perez, MD; Francis Price, Jr, MD; Eugene Protzko, MD; Harvey Reiser, MD; Stephen Smith, MD; W Colby Stewart, MD; Thomas Walters, MD.

Disclosure

Study support was provided by Bausch + Lomb, Irvine, CA, USA. The sponsor participated in the design of the study, data collection, data management, data analyses, data interpretation, preparation, review, and approval of the manuscript. The authors report no other conflicts of interest.