Keratoconjunctivitis, Vernal Clinical Trial
Official title:
A Double-blind Comparison of 0.1% Tacrolimus Ophthalmic Ointment and 2% Cyclosporine Eye Drops in the Treatment of Vernal Keratoconjunctivits (VKC)
Verified date | June 2003 |
Source | Siriraj Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ethical Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | May 2005 |
Est. primary completion date | May 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - patients with clinical diagnosis of vernal keratoconjunctivitis Exclusion Criteria: - coexisting ocular diseases such as glaucoma, other corneal disease, ocular infections, other coexisting systemic diseases |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine Siriraj Hospital | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Siriraj Hospital |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall subjective ocular symptom scores | 8 weeks | No | |
Secondary | overall objective ocular signs | 8 weeks | No | |
Secondary | overall side-effect scores | 8 weeks | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00357019 -
Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis
|
Phase 4 |