Dry Eye Syndromes Clinical Trial
Official title:
Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus
Verified date | November 2008 |
Source | Universidade Federal do Rio de Janeiro |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | November 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
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) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Universidade Federal do Rio de Janeiro | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal do Rio de Janeiro |
Brazil,
Cunningham ET Jr, Margolis TP. Ocular manifestations of HIV infection. N Engl J Med. 1998 Jul 23;339(4):236-44. Review. — View Citation
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. — View Citation
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. Erratum in: Ophthalmology 1996 Feb;103(2):204. — View Citation
Kordossis T, Paikos S, Aroni K, Kitsanta P, Dimitrakopoulos A, Kavouklis E, Alevizou V, Kyriaki P, Skopouli FN, Moutsopoulos HM. Prevalence of Sjögren's-like syndrome in a cohort of HIV-1-positive patients: descriptive pathology and immunopathology. Br J Rheumatol. 1998 Jun;37(6):691-5. — View Citation
Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. CLAO J. 1995 Oct;21(4):221-32. Review. — View Citation
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. — View Citation
Lucca JA, Kung JS, Farris RL. Keratoconjunctivitis sicca in female patients infected with human immunodeficiency virus. CLAO J. 1994 Jan;20(1):49-51. — View Citation
Lucca JA, Kung JS, Farris RL. Keratoconjunctivitis sicca in HIV-1 infected female patients. Adv Exp Med Biol. 1994;350:521-3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
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