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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 Universidade Federal do Rio de Janeiro.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00797030
First received: November 21, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

November 21, 2008
November 21, 2008
October 2006
July 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus
Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Dry Eye Syndromes
  • HIV Seropositivity
  • 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
  • Drug: sodium carboximethycellulose
    Ten HIV-positive patients with dry eye received sodium carboximethycellulose (1 drop 4 times per day) during six months
  • 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.
    Intervention: Drug: 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: Drug: sodium carboximethycellulose

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
November 2008
July 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00797030
dry eye
Yes
Rodrigo de Pinho Paes Barreto, MD, Universidade Federal do Rio de Janeiro
Universidade Federal do Rio de Janeiro
Not Provided
Principal Investigator: Rodrigo P Barreto, Masters Universidade Federal do Rio de Janeiro
Universidade Federal do Rio de Janeiro
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP