Efficacy and safety of indomethacin 0.1% eye drops compared with ketorolac 0.5% eye drops in the management of ocular inflammation after cataract surgery
Weber M, Kodjikian L, Kruse F, Zagorski Z, Allaire CM (2013)
Publication Type: Journal article
Publication year: 2013
Journal
Book Volume: 91
Pages Range: e15-21
Journal Issue: 1
DOI: 10.1111/j.1755-3768.2012.02520.x
Abstract
Purpose: To determine whether indomethacin 0.1% eye drops are at least as effective as ketorolac 0.5% eye drops in treating ocular inflammation following cataract surgery. Methods: Prospective, multicenter, investigator-masked, parallel-group, randomized, active-controlled clinical trial. Cataract patients were randomized in a 1:1 ratio to receive indomethacin or ketorolac administered QID for 3 weeks beginning 1 day before surgery. The primary end-point was aqueous flare measured by laser flare meter at postoperative Days 1 and 7. Secondary end-points included retinal thickness, slit lamp and funduscopic examinations and postsurgical pain ratings. Safety and tolerability were also assessed. Results: A total of 86 patients were included in the per protocol population (n = 43 per treatment group). Indomethacin was found non-inferior to ketorolac for comparison of aqueous flare at postoperative Days 1 and 7 (Day 1: 95% CI: -2.37, 5.50; non-inferiority upper margin, 15 ph/ms and Day 7: 95% CI: -7.83, -0.94; non-inferiority upper margin, 8 ph/ms) and statistically better than ketorolac at Day 7 (p = 0.013). There were no significant between-group differences in aqueous flare and change from baseline in retinal thickness at postoperative Days 30 and 90. Indomethacin showed a higher subjective tolerance rating than ketorolac at postoperative Days 7 and 30 (p <= 0.044). Conclusion: Indomethacin 0.1% was at least as effective as ketorolac 0.5% at Day 1 and more effective than ketorolac 0.5% at Day 7 in treating ocular inflammation after uncomplicated cataract surgery. Indomethacin was better tolerated than ketorolac. There were no clinically meaningful safety concerns with either treatment.
Authors with CRIS profile
Involved external institutions
Bausch & Lomb Incorporated
United States (USA) (US)
Medical University of Lublin / Uniwersytet Medyczny w Lublinie
Poland (PL)
Hospices Civils de Lyon (CHU)
France (FR)
Nantes University Hospital / Centre hospitalier universitaire de Nantes (CHU)
France (FR)
United States (USA) (US)
Medical University of Lublin / Uniwersytet Medyczny w Lublinie
Poland (PL)
Hospices Civils de Lyon (CHU)
France (FR)
Nantes University Hospital / Centre hospitalier universitaire de Nantes (CHU)
France (FR)
How to cite
APA:
Weber, M., Kodjikian, L., Kruse, F., Zagorski, Z., & Allaire, C.M. (2013). Efficacy and safety of indomethacin 0.1% eye drops compared with ketorolac 0.5% eye drops in the management of ocular inflammation after cataract surgery. Acta Ophthalmologica, 91(1), e15-21. https://dx.doi.org/10.1111/j.1755-3768.2012.02520.x
MLA:
Weber, Michel, et al. "Efficacy and safety of indomethacin 0.1% eye drops compared with ketorolac 0.5% eye drops in the management of ocular inflammation after cataract surgery." Acta Ophthalmologica 91.1 (2013): e15-21.
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