drugset / Trial / NCT00797030
Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus
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
- Background Cunningham ET Jr, Margolis TP. Ocular manifestations of HIV infection. N Engl J Med. 1998 Jul 23;339(4):236-44. doi: 10.1056/NEJM199807233390406. No abstract available.
- Background Kordossis T, Paikos S, Aroni K, Kitsanta P, Dimitrakopoulos A, Kavouklis E, Alevizou V, Kyriaki P, Skopouli FN, Moutsopoulos HM. Prevalence of Sjogren's-like syndrome in a cohort of HIV-1-positive patients: descriptive pathology and immunopathology. Br J Rheumatol. 1998 Jun;37(6):691-5. doi: 10.1093/rheumatology/37.6.691.
- Background DeCarlo DK, Penner SL, Schamerloh RJ, Fullard RJ. Dry eye among males infected with the human immunodeficiency virus. J Am Optom Assoc. 1995 Sep;66(9):533-8.
- Background Geier SA, Libera S, Klauss V, Goebel FD. Sicca syndrome in patients infected with the human immunodeficiency virus. Ophthalmology. 1995 Sep;102(9):1319-24. doi: 10.1016/s0161-6420(95)30868-8.
- Background Lucca JA, Kung JS, Farris RL. Keratoconjunctivitis sicca in female patients infected with human immunodeficiency virus. CLAO J. 1994 Jan;20(1):49-51.
- Background Lucca JA, Kung JS, Farris RL. Keratoconjunctivitis sicca in HIV-1 infected female patients. Adv Exp Med Biol. 1994;350:521-3. doi: 10.1007/978-1-4615-2417-5_87. No abstract available.
- Background Lucca JA, Farris RL, Bielory L, Caputo AR. Keratoconjunctivitis sicca in male patients infected with human immunodeficiency virus type 1. Ophthalmology. 1990 Aug;97(8):1008-10. doi: 10.1016/s0161-6420(90)32472-7.
- Background Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. CLAO J. 1995 Oct;21(4):221-32. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | 0.05 % | Topical |
| Background | sodium carboxymethylcellulose | Unknown | 0.5 % | Topical |