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

Universidade Federal do Rio de Janeiro

Status and phase: Unknown; Phase 4

Conditions: Dry Eye Syndromes; HIV Seropositivity

Treatments: Drug: sodium carboximethycellulose; Drug: cyclosporine and sodium carboximethycellulose

Study type: Interventional

Funder types: Other

Identifiers

NCT00797030

dry eye

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

1

Active Comparator group

Description:

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.

Treatment:

Drug: cyclosporine and sodium carboximethycellulose

2

Other group

Description:

Ten HIV-positive-patients with dry eye received sodium carboximethylcelullose 0.5% (1 drop 4 times per day) during six months

Treatment:

Drug: sodium carboximethycellulose