Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|