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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Eye Syndromes, HIV Seropositivity

Intervention / Treatment
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* Drug: cyclosporine and sodium carboximethycellulose
* Drug: sodium carboximethycellulose


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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. | Drug: cyclosporine and sodium carboximethycellulose<br>* 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<br>|
| Other: 2<br>Ten HIV-positive-patients with dry eye received sodium carboximethylcelullose 0.5% (1 drop 4 times per day) during six months | Drug: sodium carboximethycellulose<br>* Ten HIV-positive patients with dry eye received sodium carboximethycellulose (1 drop 4 times per day) during six months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye syndromes, keratoconjuntivitis sicca / drug therapy, cyclosporine, ophthalmic solutions, HIV seropositivity