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

Primary Purpose

Dry Eye Syndromes, HIV Seropositivity

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
cyclosporine and sodium carboximethycellulose
sodium carboximethycellulose
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring dry eye syndromes, keratoconjuntivitis sicca / drug therapy, cyclosporine, ophthalmic solutions, HIV seropositivity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • Universidade Federal do Rio de Janeiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

1

2

Arm 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.

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

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2008
Last Updated
November 21, 2008
Sponsor
Universidade Federal do Rio de Janeiro
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1. Study Identification

Unique Protocol Identification Number
NCT00797030
Brief Title
Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus
Official Title
Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
July 2008 (Anticipated)
Study Completion Date
November 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade Federal do Rio de Janeiro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, HIV Seropositivity
Keywords
dry eye syndromes, keratoconjuntivitis sicca / drug therapy, cyclosporine, ophthalmic solutions, HIV seropositivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm 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.
Arm Title
2
Arm Type
Other
Arm Description
Ten HIV-positive-patients with dry eye received sodium carboximethylcelullose 0.5% (1 drop 4 times per day) during six months
Intervention Type
Drug
Intervention Name(s)
cyclosporine and sodium carboximethycellulose
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
sodium carboximethycellulose
Intervention Description
Ten HIV-positive patients with dry eye received sodium carboximethycellulose (1 drop 4 times per day) during six months
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo P Barreto, Masters
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio de Janeiro
City
Rio de Janeiro
ZIP/Postal Code
21941-913
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
9673303
Citation
Cunningham ET Jr, Margolis TP. Ocular manifestations of HIV infection. N Engl J Med. 1998 Jul 23;339(4):236-44. doi: 10.1056/NEJM199807233390406. No abstract available.
Results Reference
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PubMed Identifier
9667626
Citation
Kordossis T, Paikos S, Aroni K, Kitsanta P, Dimitrakopoulos A, Kavouklis E, Alevizou V, Kyriaki P, Skopouli FN, Moutsopoulos HM. Prevalence of Sjogren's-like syndrome in a cohort of HIV-1-positive patients: descriptive pathology and immunopathology. Br J Rheumatol. 1998 Jun;37(6):691-5. doi: 10.1093/rheumatology/37.6.691.
Results Reference
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PubMed Identifier
7490413
Citation
DeCarlo DK, Penner SL, Schamerloh RJ, Fullard RJ. Dry eye among males infected with the human immunodeficiency virus. J Am Optom Assoc. 1995 Sep;66(9):533-8.
Results Reference
background
PubMed Identifier
9097769
Citation
Geier SA, Libera S, Klauss V, Goebel FD. Sicca syndrome in patients infected with the human immunodeficiency virus. Ophthalmology. 1995 Sep;102(9):1319-24. doi: 10.1016/s0161-6420(95)30868-8. Erratum In: Ophthalmology 1996 Feb;103(2):204.
Results Reference
background
PubMed Identifier
8149575
Citation
Lucca JA, Kung JS, Farris RL. Keratoconjunctivitis sicca in female patients infected with human immunodeficiency virus. CLAO J. 1994 Jan;20(1):49-51.
Results Reference
background
PubMed Identifier
8030528
Citation
Lucca JA, Kung JS, Farris RL. Keratoconjunctivitis sicca in HIV-1 infected female patients. Adv Exp Med Biol. 1994;350:521-3. doi: 10.1007/978-1-4615-2417-5_87. No abstract available.
Results Reference
background
PubMed Identifier
2402409
Citation
Lucca JA, Farris RL, Bielory L, Caputo AR. Keratoconjunctivitis sicca in male patients infected with human immunodeficiency virus type 1. Ophthalmology. 1990 Aug;97(8):1008-10. doi: 10.1016/s0161-6420(90)32472-7.
Results Reference
background
PubMed Identifier
8565190
Citation
Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. CLAO J. 1995 Oct;21(4):221-32. No abstract available.
Results Reference
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Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus

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