ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00797030
Recruitment Status : Unknown
Verified November 2008 by Universidade Federal do Rio de Janeiro.
Recruitment status was:  Active, not recruiting
First Posted : November 24, 2008
Last Update Posted : November 24, 2008
Sponsor:
Information provided by:
Universidade Federal do Rio de Janeiro

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 Type : Interventional  (Clinical Trial)
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 : October 2006
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

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

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
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



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. [ Time Frame: six months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797030


Locations
Brazil
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

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
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: November 24, 2008
Last Verified: November 2008

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

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