Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus
|ClinicalTrials.gov Identifier: NCT00797030|
Recruitment Status : Unknown
Verified November 2008 by Universidade Federal do Rio de Janeiro.
Recruitment status was: Active, not recruiting
First Posted : November 24, 2008
Last Update Posted : November 24, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndromes HIV Seropositivity||Drug: cyclosporine and sodium carboximethycellulose Drug: sodium carboximethycellulose||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus|
|Study Start Date :||October 2006|
|Estimated Primary Completion Date :||July 2008|
|Estimated Study Completion Date :||November 2008|
Active Comparator: 1
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
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
Ten HIV-positive-patients with dry eye received sodium carboximethylcelullose 0.5% (1 drop 4 times per day) during six months
Drug: sodium carboximethycellulose
Ten HIV-positive patients with dry eye received sodium carboximethycellulose (1 drop 4 times per day) during six months
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797030
|Universidade Federal do Rio de Janeiro|
|Rio de Janeiro, Brazil, 21941-913|
|Principal Investigator:||Rodrigo P Barreto, Masters||Universidade Federal do Rio de Janeiro|