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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.
Last refreshed on: 19 February 2015
Main ID:  NCT01850979
Date of registration: 01/05/2013
Prospective Registration: No
Primary sponsor: University of Sao Paulo General Hospital
Public title: Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops
Scientific title: Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops: Prospective Double-Blind Randomized Study
Date of first enrolment: February 2010
Target sample size: 24
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Name:     ruth m santo, assistent
Affiliation:  University of Sao Paulo General Hospital
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Dry Eye Syndrome
Sjogren Syndrome
Drug: Olive Oil
Drug: Tacrolimus
Primary Outcome(s)
Evaluation of the quantity of lacrimal film [Time Frame: 90 days]
Secondary Outcome(s)
Evaluation of quality of lacrimal film [Time Frame: 90 days]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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