Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus

Phase 4

• Conditions: Dry Eye Syndromes; HIV Seropositivity
• Interventions: Drug: cyclosporine and sodium carboximethycellulose; Drug: sodium carboximethycellulose

• Registration Number: NCT00797030
• Lead Sponsor: Universidade Federal do Rio de Janeiro

Brief Summary

This study evaluates the use of topical cyclosporine 0.05% and sodium carboxymethylcellulose 0.5% for the treatment of dry eye disease in patients infected with the human immunodeficiency virus.

Twenty HIV-positive-patients were selected from the Department of Infectious Diseases of the Federal University of Rio de Janeiro Hospital. Dry eye diagnosis was based on a dry eye questionnaire (Ocular Surface Disease Index - OSDI®), Schirmer I Test, break up time and 1% rose bengal staining of the ocular surface. The patients were divided into two groups with ten patients. Group I received sodium carboxymethylcellulose 0.5% drops and group II received sodium carboxymethylcellulose 0,5% drops and topical cyclosporine 0.05% for six months.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2008-07
• Status Verified: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Last Update Submitted: 2008-11-21
• Study First Posted: 2008-11-24
• Last Update Posted: 2008-11-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• HIV seropositivity
• Dry eye diagnosis

Exclusion Criteria

• Hepatitis B infection
• Hepatitis C infection
• Menopause
• Rheumatic diseases
• Contact lens wear
• Beta-blocker eye drops
• Blepharitis
• Use of medications associated with dry eye (diuretics, antidepressive agents, beta-blockers)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	cyclosporine and sodium carboximethycellulose	Ten HIV-positive-patients with dry eye diagnosis received sodium carboxymethylcellulose 0.5% drops (one drop 4 times per day) and topical cyclosporine 0.05% (one drop twice a day) for six months.
2	sodium carboximethycellulose	Ten HIV-positive-patients with dry eye received sodium carboximethylcelullose 0.5% (1 drop 4 times per day) during six months

Primary Outcome Measures

Name	Time	Method
Dry eye diagnosis was based on a dry eye questionnaire (OSDI), Shirmer I Test, BUT and 1% rose bengal staining of the ocular surface. The same tests were performed at the end of the treatment to verify the improvement of the subjects.	six months

Trial Locations

Locations (1)

Universidade Federal do Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil