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

Phase 4

Completed

• Conditions: Cataract; Inflammation
• Interventions: Drug: Indomethacin ophthalmic solution; Drug: Ketorolac Ophthalmic Solution

• Registration Number: NCT00904904
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Primary Completion: 2009-06
• Study Completion: 2009-09
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-10
• Last Update Posted: 2012-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indomethacin	Indomethacin ophthalmic solution	Indomethacin ophthalmic solution 0.1% for post-surgical inflammation
Ketorolac	Ketorolac Ophthalmic Solution	Ketorolac ophthalmic solution 0.5% for post-surgical inflammation

Primary Outcome Measures

Name	Time	Method
Aqueous flare	Post-operative day 1 & day 7

Secondary Outcome Measures

Name	Time	Method
Change from baseline of retinal thickness	Postoperative day 30 & day 90
Aqueous flare	Postoperative day 30 and day 90

Trial Locations

Locations (1)

Bausch & Lomb; 🇩🇪 Berlin, Germany