Overview

This trial is active, not recruiting.

Conditions dry eye syndromes, hiv seropositivity
Treatments cyclosporine and sodium carboximethycellulose, sodium carboximethycellulose
Phase phase 4
Sponsor Universidade Federal do Rio de Janeiro
Start date October 2006
End date July 2008
Trial size 20 participants
Trial identifier NCT00797030, dry eye

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
cyclosporine and sodium carboximethycellulose
Ten HIV-positive patients with dry eye received sodium carboximethylcellulose 0.5% (one drop 4 times per day) and topical cyclosporine 0.05% (one drop twice a day) during six months
(Other)
Ten HIV-positive-patients with dry eye received sodium carboximethylcelullose 0.5% (1 drop 4 times per day) during six months
sodium carboximethycellulose
Ten HIV-positive patients with dry eye received sodium carboximethycellulose (1 drop 4 times per day) during six months

Primary Outcomes

Measure
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.
time frame: six months

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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)

Additional Information

Official title Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus
Principal investigator Rodrigo P Barreto, Masters
Trial information was received from ClinicalTrials.gov and was last updated in November 2008.
Information provided to ClinicalTrials.gov by Universidade Federal do Rio de Janeiro.