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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT00335114
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 8.1

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Wearers With Dry Eye Syndrome	Drug: cyclosporine ophthalmic emulsion	N/A

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers
• Study Start Date: Nov 1, 2005
• Study Completion Date: Apr 1, 2006

Outcome Measures

Primary Outcome Measures

1. Ocular exams and questionnaires at baseline and at 3 months will determine []

2. the effect of cyclosporine on dry eye syndrome. []

Secondary Outcome Measures

1. Increased contact lens wearing time due to a decrease in severity []

2. of dry eye symptoms []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• contact lens wearer

• clinical diagnosis of dry eye syndrome

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Ophthalmology Services Foundation	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00335114
• Other Study ID Numbers: F051025017
• First Posted: Jun 8, 2006
• Last Update Posted: Jun 9, 2006
• Last Verified: Jun 1, 2006

• Keywords provided by , ,: cyclosporine, dry eye syndrome, contact lens
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome; Cyclosporine; Cyclosporins

Study Results

No Results Posted as of Jun 9, 2006