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)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00357019 -
Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis
|
Phase 4 |