A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery

September 29, 2009 updated by: Allergan
This is a 16-day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Phase 3

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

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:

  • Patients undergoing cataract surgery

Exclusion Criteria:

  • Uncontrolled ocular disease in cataract surgery eye

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ketorolac

Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day.

Placebo
Placebo Comparator: 2
Drug: ketorolac

Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day.

Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of Post Operative Inflammation
Time Frame: Day 14
Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = >50 cells)
Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Pain
Time Frame: Day 1
Measured on a scale of 0-4 (0 = none, 4 = intolerable)
Day 1
Mean Pupil Area
Time Frame: Day 0
Pupil area post-irrigation and aspiration
Day 0

Collaborators and Investigators

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

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

October 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

August 30, 2007

First Submitted That Met QC Criteria

August 30, 2007

First Posted (Estimate)

September 3, 2007

Study Record Updates

Last Update Posted (Estimate)

October 1, 2009

Last Update Submitted That Met QC Criteria

September 29, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191578-005

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.

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