Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

February 17, 2009 updated by: Florida Eye Microsurgical Institute

Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients

To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

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

  • United States
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Florida Eye Microsurgical Institute

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:

  • Must be in general good health
  • Diagnosis of moderate to severe dry eye syndrome

Exclusion Criteria:

  • Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy
  • Patients who are pregnant or nursing females
  • Unwilling to discontinue use of contact lenses during the run-in and duration of the study
  • Presence or history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of the study results in the study eye
  • Previous treatment failure on CSA 0.05% (Restasis)
  • Known hypersensitivity to any component of the study or procedural medications
  • Participation in any other clinical trial within 30 days prior to screening
  • Known contraindication to any study medication or any of their components.
  • Should not be taking any oral anti-histamines, beta blockers or diuretics.

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
Active Comparator: 1
Active treatment arm bromfenac 0.09% BID for 6 weeks
Drug: bromfenac
0.09%, BID, 6 weeks
Active Comparator: 2
ketorolac 0.4% BID for 6 weeks
Drug: ketorolac
0.4%, BID, 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ocular comfort
Time Frame: six weeks
six weeks

Collaborators and Investigators

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

Sponsor

Florida Eye Microsurgical Institute

Collaborators

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

August 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

August 21, 2007

First Submitted That Met QC Criteria

August 22, 2007

First Posted (Estimate)

August 23, 2007

Study Record Updates

Last Update Posted (Estimate)

February 19, 2009

Last Update Submitted That Met QC Criteria

February 17, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sch012007

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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