drugset / Trial / NCT00797030

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

NCT00797030

Phase 4 Unknown 20 enrolled Federal University of Rio de Janeiro
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-10
Primary completion
2008-07
Completion
2008-11

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide 0.05 % Topical
Background sodium carboxymethylcellulose Unknown 0.5 % Topical

Indications