Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)
NCT01068054 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2010-02-12
Summary
The study was a double-blind, parallel study to compare efficacy of 0.1% tacrolimus ophthalmic ointment vs 2% cyclosporine eye drops in children with vernal keratoconjunctivitis. The duration of the blinded period was 8 weeks followed with 4 weeks of open-period of tacrolimus ointment. The hypothesis was that tacrolimus was as effective as cyclosporine for the treatment of this condition.
Conditions
- Keratoconjunctivitis, Vernal
Interventions
- DRUG
-
0.1% ointment,apply bid, 8 weeks
- DRUG
-
cyclosporins
2% eyclosporine eye drops apply 1 drop to each eye QID
Sponsors & Collaborators
-
Siriraj Hospital
lead OTHER
Principal Investigators
-
Pakit Vichyanond, MD · Siriraj Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-06-30
- Primary Completion
- 2005-05-31
- Completion
- 2005-05-31
Countries
- Thailand
Study Locations
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