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

NCT ID: NCT00904904

Last Updated: 2012-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-09-30

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.

Conditions

Cataract; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Indomethacin

Indomethacin ophthalmic solution 0.1% for post-surgical inflammation

Group Type: EXPERIMENTAL

Indomethacin ophthalmic solution

Intervention Type: DRUG

Indomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery

Ketorolac

Ketorolac ophthalmic solution 0.5% for post-surgical inflammation

Group Type: ACTIVE_COMPARATOR

Ketorolac Ophthalmic Solution

Intervention Type: DRUG

Ketorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery

Interventions

Indomethacin ophthalmic solution

Indomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery

Intervention Type: DRUG

Ketorolac Ophthalmic Solution

Ketorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriele Brenger

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb

Berlin, , Germany

Countries

Germany

Other Identifiers

2007-004686-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

539

Identifier Type: -

Identifier Source: org_study_id