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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Federal University of Rio de Janeiro.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00797030
First received: November 21, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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 Intervention Phase
Dry Eye Syndromes
HIV Seropositivity
 Drug: cyclosporine and sodium carboximethycellulose
Drug: sodium carboximethycellulose
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Federal University of Rio de Janeiro:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: October 2006
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797030

Locations
Brazil
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil, 21941-913
Sponsors and Collaborators
Federal University of Rio de Janeiro
Investigators
Principal Investigator: Rodrigo P Barreto, Masters Federal University of Rio de Janeiro
  More Information

Publications:

Responsible Party: Rodrigo de Pinho Paes Barreto, MD, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT00797030     History of Changes
Other Study ID Numbers: dry eye
Study First Received: November 21, 2008
Last Updated: November 21, 2008
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Rio de Janeiro:
dry eye syndromes
keratoconjuntivitis sicca / drug therapy
cyclosporine
ophthalmic solutions
HIV seropositivity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Dry Eye Syndromes
Keratoconjunctivitis Sicca
HIV Seropositivity
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Lacrimal Apparatus Diseases
 Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents

ClinicalTrials.gov processed this record on May 21, 2013