Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to show that indomethacin is at least as effective as ketorolac for the prevention of ocular inflammation following cataract surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Indomethacin; Ketorolac; Ketorolac Tromethamine; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Subjects must be planning to undergo cataract surgery on one eye by phacoemulsification with posterior chamber intraocular lens, using topical or general anaesthesia.

• Subjects must have a preoperative flare ≤ 15 ph/ms, measured with a laser flare meter(LFM) without pharmacological pupil dilation, within the 2 months preoperatively.

Exclusion Criteria:

• Subjects who have any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents.

• Subjects who take acetylsalicylic acid at doses > 100 mg daily and cannot discontinue usage during the study.

• Subjects who have a history of asthma linked to acetylsalicylic acid or other nonsteroidal anti-inflammatory (NSAI) drug administration.

• Subjects with immunodepression.

• Subjects with a history of intolerance to the study drug or to any NSAI drug.

• Subjects who are monocular for any reason other than cataract.

• Subjects who are treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion.