Status:
COMPLETED
Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Sjogren Syndrome
Dry Eye Syndrome
Eligibility:
All Genders
40-60 years
Phase:
PHASE4
Brief Summary
Aqueous deficiency dry eye is mainly caused by Sjogren syndrome (SS), an autoimmune, chronic, inflammatory and systemic disease which affects most commonly the lacrimal and salivary glands.The ocular ...
Detailed Description
Aqueous deficiency dry eye is mainly caused by Sjogren syndrome (SS), an autoimmune, chronic, inflammatory and systemic disease which affects most commonly the lacrimal and salivary glands. The hyperr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01850979
Start Date
February 1 2010
End Date
November 1 2011
Last Update
May 10 2013
Active Locations (1)
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1
University of Sao Paulo General Hospital
São Paulo, São Paulo, Brazil, 05403000