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

August 10, 2012 updated by: Bausch & Lomb Incorporated
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, D 13581
        • Bausch & Lomb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aqueous flare
Time Frame: Post-operative day 1 & day 7
Post-operative day 1 & day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Aqueous flare
Time Frame: Postoperative day 30 and day 90
Postoperative day 30 and day 90
Change from baseline of retinal thickness
Time Frame: Postoperative day 30 & day 90
Postoperative day 30 & day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Gabriele Brenger, Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Estimate)

August 13, 2012

Last Update Submitted That Met QC Criteria

August 10, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 539
  • 2007-004686-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe