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

• Sponsor: Universidade Federal do Rio de Janeiro (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00797030
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes; HIV Seropositivity	Drug: cyclosporine and sodium carboximethycellulose; Drug: sodium carboximethycellulose	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus
• Study Start Date: Oct 1, 2006
• Anticipated Primary Completion Date: Jul 1, 2008
• Anticipated Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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
Other: 2 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

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Federal do Rio de Janeiro	Rio de Janeiro		Brazil	21941-913

Sponsors and Collaborators

• Universidade Federal do Rio de Janeiro

Investigators

• Principal Investigator: Rodrigo P Barreto, Masters, Universidade Federal do Rio de Janeiro

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cunningham ET Jr, Margolis TP. Ocular manifestations of HIV infection. N Engl J Med. 1998 Jul 23;339(4):236-44. Review.
• 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.
• 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.
• 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.
• 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.
• 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.
• Lucca JA, Kung JS, Farris RL. Keratoconjunctivitis sicca in female patients infected with human immunodeficiency virus. CLAO J. 1994 Jan;20(1):49-51.
• Lucca JA, Kung JS, Farris RL. Keratoconjunctivitis sicca in HIV-1 infected female patients. Adv Exp Med Biol. 1994;350:521-3.

• ClinicalTrials.gov Identifier: NCT00797030
• Other Study ID Numbers: dry eye
• First Posted: Nov 24, 2008
• Last Update Posted: Nov 24, 2008
• Last Verified: Nov 1, 2008

• Keywords provided by , ,: dry eye syndromes; keratoconjuntivitis sicca / drug therapy; cyclosporine; ophthalmic solutions; HIV seropositivity
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; HIV Seropositivity; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Cyclosporine; Cyclosporins

Study Results

No Results Posted as of Nov 24, 2008