Back to resultsEfficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers
Primary Purpose
Contact Lens Wearers With Dry Eye Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cyclosporine ophthalmic emulsion
Sponsored by
About this trial
This is an interventional treatment trial for Contact Lens Wearers With Dry Eye Syndrome focused on measuring cyclosporine, dry eye syndrome, contact lens
Eligibility Criteria
Inclusion Criteria: contact lens wearer clinical diagnosis of dry eye syndrome Exclusion Criteria: -
Sites / Locations
- UAB Ophthalmology Services Foundation
Outcomes
Primary Outcome Measures
Ocular exams and questionnaires at baseline and at 3 months will determine
the effect of cyclosporine on dry eye syndrome.
Secondary Outcome Measures
Increased contact lens wearing time due to a decrease in severity
of dry eye symptoms
Full Information
NCT ID
NCT00335114
First Posted
June 7, 2006
Last Updated
May 5, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT00335114
Brief Title
Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers
Official Title
Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Lens Wearers With Dry Eye Syndrome
Keywords
cyclosporine, dry eye syndrome, contact lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cyclosporine ophthalmic emulsion
Primary Outcome Measure Information:
Title
Ocular exams and questionnaires at baseline and at 3 months will determine
Title
the effect of cyclosporine on dry eye syndrome.
Secondary Outcome Measure Information:
Title
Increased contact lens wearing time due to a decrease in severity
Title
of dry eye symptoms
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
contact lens wearer
clinical diagnosis of dry eye syndrome
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol E Rosenstiel, OD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Ophthalmology Services Foundation
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers
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