Trial | NCT01068054  Report issue

Title

Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)
A Double-blind Comparison of 0.1% Tacrolimus Ophthalmic Ointment and 2% Cyclosporine Eye Drops in the Treatment of Vernal Keratoconjunctivits (VKC)

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
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.
Study Started
Jun 30
2003
Primary Completion
May 31
2005
Study Completion
May 31
2005
Last Update
Feb 12
2010
Estimate

Drug tacrolimus

0.1% ointment,apply bid, 8 weeks

Drug cyclosporins

2% eyclosporine eye drops apply 1 drop to each eye QID

tacrolimus Active Comparator

Tacrolimus arm: active 0.1% tacrolimus eye ointment BID + placebo eye drops QID

cyclosporine Active Comparator

2% cyclosporine eye drops apply QID + placebo eye ointment apply bid

Criteria 

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
No Results Posted