Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-blind Comparison of 0.1% Tacrolimus Ophthalmic Ointment and 2% Cyclosporine Eye Drops in the Treatment of Vernal Keratoconjunctivits (VKC)|
- overall subjective ocular symptom scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- overall objective ocular signs [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- overall side-effect scores [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2003|
|Study Completion Date:||May 2005|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
Active Comparator: tacrolimus
Tacrolimus arm: active 0.1% tacrolimus eye ointment BID + placebo eye drops QID
0.1% ointment,apply bid, 8 weeks
Active Comparator: cyclosporine
2% cyclosporine eye drops apply QID + placebo eye ointment apply bid
2% eyclosporine eye drops apply 1 drop to each eye QID
Background: Vernal keratoconjunctivitis (VKC) is a serious, sight-threatening ocular disease, occurring mainly in children. Prolonged use of ophthalmic corticosteroids is usually required in severe cases which could lead to serious complications such as glaucoma and cataract. Cyclosporine and tacrolimus are among newer treatments for VKC.
Objective: To compare the efficacy of 0.1% tacrolimus (FK-506) ophthalmic ointment with 2% cyclosporine eye drops in the treatment of VKC.
Methods: Twenty-four patients with VKC were recruited. After a 2 week-washout period, they were randomized into 2 groups in a double-blinded, parallel fashion. The first group received 0.1% FK-506 eye ointment with placebo eye drops and the second group received 2% cyclosporine eye drops with placebo ointment for 8 weeks. Thereafter, all patients received an open-treatment with 0.1% FK-506 eye ointment for another 4 weeks. Subjective ocular symptoms and side effects were scored by patients at the entry, and at the end of the 1st, 4th, 8th and 12th weeks. Objective ocular signs were evaluated by an ophthalmologist (PK) at all follow up visits.