Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)

Sponsor

Siriraj Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01068054

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis, Vernal	Drug: tacrolimus Drug: cyclosporins	Phase 2/Phase 3

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, 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)

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

May 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: tacrolimus Tacrolimus arm: active 0.1% tacrolimus eye ointment BID + placebo eye drops QID	Drug: tacrolimus 0.1% ointment,apply bid, 8 weeks
Active Comparator: cyclosporine 2% cyclosporine eye drops apply QID + placebo eye ointment apply bid	Drug: cyclosporins 2% eyclosporine eye drops apply 1 drop to each eye QID

Arm

Intervention/Treatment

Active Comparator: tacrolimus

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

Drug: tacrolimus

0.1% ointment,apply bid, 8 weeks

Active Comparator: cyclosporine

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

Drug: cyclosporins

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