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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01850979 |
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Date of registration:
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01/05/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops
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Scientific title:
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Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops: Prospective Double-Blind Randomized Study |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01850979 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Brazil
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Contacts
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Name:
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ruth m santo, assistent |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Sao Paulo General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- SS was diagnosed according to the SS European Criteria
- chronic symptoms of burning, foreign body sensation, itching in both eyes
- daily need of artificial tears
- abnormal Schirmer (ST) I test < 5mm or rose Bengal staining (RBS) = 4, or break up
time (BUT) < 5 seconds.
Exclusion Criteria:
- any structural abnormalities (lid scarring, entropion, trichiasis, etc.)
- any inflammation or active structural change in the iris or anterior chamber
- glaucoma
- previous eye surgery or punctual occlusion
- use of any other topical medication other than artificial tears
- any systemic or topical antibacterial or antiinflammatory drug treatment 90 days
before study entry
- contact lens wearer
- the presence of any corneal infection
- any corneal diseases (marginal ulcer, opacity, scar, bullous keratopathy,
conjunctivochalasis, symblepharon or tumor)
- pregnancy
- change in the immunosuppressive systemic therapy 90 days before study entry
Age minimum:
40 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sjogren Syndrome
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Dry Eye Syndrome
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Intervention(s)
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Drug: Olive Oil
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Drug: Tacrolimus
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Primary Outcome(s)
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Evaluation of the quantity of lacrimal film
[Time Frame: 90 days]
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Secondary Outcome(s)
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Evaluation of quality of lacrimal film
[Time Frame: 90 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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