Document Detail

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.
MedLine Citation:
PMID:  22970738     Owner:  NLM     Status:  Publisher    
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.
Michel Weber; Laurent Kodjikian; Friedrich E Kruse; Zbigniew Zagorski; Catherine M Allaire
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-12
Journal Detail:
Title:  Acta ophthalmologica     Volume:  -     ISSN:  1755-3768     ISO Abbreviation:  Acta Ophthalmol     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-13     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101468102     Medline TA:  Acta Ophthalmol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2012 Bosch and Lomb. Acta Ophthalmologica © 2012 Acta Ophthalmologica Scandinavica Foundation.
Department of Ophthalmology, Hotel Dieu University Hospital, Nantes, France Department of Ophthalmology, Croix Rousse University Hospital, Lyon, France Department of Ophthalmology, University of Erlangen, Erlangen, Germany Department of Ophthalmology, Medical University, Lublin, Poland European Pharmaceutical Clinical Sciences, Bausch & Lomb, Evry, France.
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