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

Beitrag in einer Fachzeitschrift


Details zur Publikation

Autor(en): Weber M, Kodjikian L, Kruse F, Zagorski Z, Allaire CM
Zeitschrift: Acta Ophthalmologica
Jahr der Veröffentlichung: 2013
Band: 91
Heftnummer: 1
Seitenbereich: e15-21
ISSN: 1755-375X


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.


FAU-Autoren / FAU-Herausgeber

Kruse, Friedrich Prof. Dr.
Lehrstuhl für Augenheilkunde


Autor(en) der externen Einrichtung(en)
Bausch & Lomb Incorporated
CHU de Nantes
Hospices Civils de Lyon (CHU)
Medical University of Lublin / Uniwersytet Medyczny w Lublinie


Zitierweisen

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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Zuletzt aktualisiert 2018-05-10 um 02:22