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

Sponsor

Bausch & Lomb Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT00904904

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Inflammation	Drug: Indomethacin ophthalmic solution Drug: Ketorolac Ophthalmic Solution	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Indomethacin Indomethacin ophthalmic solution 0.1% for post-surgical inflammation	Drug: Indomethacin ophthalmic solution Indomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery
Active Comparator: Ketorolac Ketorolac ophthalmic solution 0.5% for post-surgical inflammation	Drug: Ketorolac Ophthalmic Solution Ketorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery

Arm

Intervention/Treatment

Experimental: Indomethacin

Indomethacin ophthalmic solution 0.1% for post-surgical inflammation

Drug: Indomethacin ophthalmic solution

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

Active Comparator: Ketorolac

Ketorolac ophthalmic solution 0.5% for post-surgical inflammation

Drug: Ketorolac Ophthalmic Solution

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

Outcome Measures

Primary Outcome Measures

Aqueous flare [Post-operative day 1 & day 7]

Secondary Outcome Measures

Aqueous flare [Postoperative day 30 and day 90]
Change from baseline of retinal thickness [Postoperative day 30 & day 90]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.