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Clinical Trials/NCT00797030
NCT00797030
Unknown
Phase 4

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

Universidade Federal do Rio de Janeiro1 site in 1 country20 target enrollmentOctober 2006

Overview

Phase
Phase 4
Intervention
cyclosporine and sodium carboximethycellulose
Conditions
Dry Eye Syndromes
Sponsor
Universidade Federal do Rio de Janeiro
Enrollment
20
Locations
1
Primary Endpoint
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.
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2006
End Date
November 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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)

Arms & Interventions

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.

Intervention: cyclosporine and sodium carboximethycellulose

2

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

Intervention: sodium carboximethycellulose

Outcomes

Primary Outcomes

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.

Time Frame: six months

Study Sites (1)

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