Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers

May 5, 2023 updated by: Carol E. Rosenstiel, University of Alabama at Birmingham
Cyclosporine Ophthalmic Emulsion is currently used in the treatment of dry eye syndrome. Contact lens wearers frequently suffer from dry eye syndrome. The purpose of this study is to evaluate cyclosporine ophthalmic emulsion verses re-wetting drops in the relief of dry eye symptoms in contact lens wearers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Not Applicable

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
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • UAB Ophthalmology Services Foundation

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • contact lens wearer
  • clinical diagnosis of dry eye syndrome

Exclusion Criteria:

-

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ocular exams and questionnaires at baseline and at 3 months will determine
the effect of cyclosporine on dry eye syndrome.

Secondary Outcome Measures

Outcome Measure
Increased contact lens wearing time due to a decrease in severity
of dry eye symptoms

Collaborators and Investigators

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

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Carol E Rosenstiel, OD, University of Alabama at Birmingham

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

November 1, 2005

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

June 7, 2006

First Submitted That Met QC Criteria

June 7, 2006

First Posted (Estimate)

June 8, 2006

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F051025017

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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