Dry Eye SyndromesPhase 4NCT00797030
Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus
A Phase 4 study testing cyclosporine and sodium carboximethycellulose and sodium carboximethycellulose in people with Dry Eye Syndromes and HIV Seropositivity, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Dry Eye Syndromes, HIV Seropositivity
- What is being tested?
- cyclosporine and sodium carboximethycellulose and sodium carboximethycellulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2006to Nov 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV seropositivity
- Dry eye diagnosis
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-913
About this study
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.
- Conditions
- Dry Eye Syndromes, HIV Seropositivity
- Being tested
- cyclosporine and sodium carboximethycellulose, sodium carboximethycellulose
- Keywords
- dry eye syndromes, keratoconjuntivitis sicca / drug therapy, cyclosporine, ophthalmic solutions, HIV seropositivity
- Medical subject headings
- Dry Eye Syndromes, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporine and sodium carboximethycelluloseDrug
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
sodium carboximethycelluloseDrug
Ten HIV-positive patients with dry eye received sodium carboximethycellulose (1 drop 4 times per day) during six months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 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. Receives: Drug: cyclosporine and sodium carboximethycellulose |
| 2 | Other | Ten HIV-positive-patients with dry eye received sodium carboximethylcelullose 0.5% (1 drop 4 times per day) during six months Receives: Drug: sodium carboximethycellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startOct 2006
- Primary completionJul 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Investigators
- Rodrigo P Barreto, Masters, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797030
- Sponsor's protocol ID
- dry eye
- Status last verified
- Nov 2008
- First submitted
- 21 Nov 2008
- Last updated
- 24 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9673303Kordossis 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.
PubMed 9667626DeCarlo 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.
PubMed 7490413Geier 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.
PubMed 9097769Lucca JA, Kung JS, Farris RL. Keratoconjunctivitis sicca in female patients infected with human immunodeficiency virus. CLAO J. 1994 Jan;20(1):49-51.
PubMed 8149575Lucca 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.
PubMed 8030528Lucca 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.
PubMed 2402409Lemp 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.
PubMed 8565190
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus
- ClinicalTrials.gov ID
- NCT00797030
- Acronym / sponsor ID
- dry eye
- Conditions
- Dry Eye Syndromes, HIV Seropositivity
- Keywords
- dry eye syndromes, keratoconjuntivitis sicca / drug therapy, cyclosporine, ophthalmic solutions, HIV seropositivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: cyclosporine and sodium carboximethycelluloseTen 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. |
| 2 | Other | Drug: sodium carboximethycelluloseTen HIV-positive-patients with dry eye received sodium carboximethylcelullose 0.5% (1 drop 4 times per day) during six months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- HIV seropositivity
- Dry eye diagnosis
Key exclusion criteria (8 listed)
- Hepatitis B infection
- Hepatitis C infection
- Menopause
- Rheumatic diseases
- Contact lens wear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cyclosporine and sodium carboximethycelluloseTen 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 | 1 |
| sodium carboximethycelluloseTen HIV-positive patients with dry eye received sodium carboximethycellulose (1 drop 4 times per day) during six months | Drug | 2 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2008.
- Background: PubMed 9673303Cunningham 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.
- Background: PubMed 9667626Kordossis 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.
- Background: PubMed 7490413DeCarlo 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.
- Background: PubMed 9097769Geier 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.
- Background: PubMed 8149575Lucca JA, Kung JS, Farris RL. Keratoconjunctivitis sicca in female patients infected with human immunodeficiency virus. CLAO J. 1994 Jan;20(1):49-51.
- Background: PubMed 8030528Lucca 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.
- Background: PubMed 2402409Lucca 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.
- Background: PubMed 8565190Lemp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo P Barreto, Masters principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cyclosporine and sodium carboximethycellulose and sodium carboximethycellulose in people with Dry Eye Syndromes and HIV Seropositivity, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00797030, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2008.