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

NCT ID: NCT00904904

Last Updated: 2012-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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Conditions

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Cataract Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

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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

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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

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriele Brenger

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Bausch & Lomb

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2007-004686-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

539

Identifier Type: -

Identifier Source: org_study_id