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

Bausch + Lomb

Status and phase

Completed

Phase 4

Conditions

Inflammation

Cataract

Treatments

Drug: Indomethacin ophthalmic solution

Drug: Ketorolac Ophthalmic Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT00904904

539

2007-004686-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.