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

Phase 2

Completed

• Conditions: Keratoconjunctivitis, Vernal
• Interventions: Drug: tacrolimus; Drug: cyclosporins

• Registration Number: NCT01068054
• Lead Sponsor: Siriraj Hospital

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.

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 Timeline

• Status Verified: 2003-06
• Study Start: 2003-06
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Study First Submitted: 2010-02-11
• Study First Submitted QC: 2010-02-11
• Last Update Submitted: 2010-02-11
• Study First Posted: 2010-02-12
• Last Update Posted: 2010-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tacrolimus	tacrolimus	Tacrolimus arm: active 0.1% tacrolimus eye ointment BID + placebo eye drops QID
cyclosporine	cyclosporins	2% cyclosporine eye drops apply QID + placebo eye ointment apply bid

Primary Outcome Measures

Name	Time	Method
overall subjective ocular symptom scores	8 weeks

Secondary Outcome Measures

Name	Time	Method
overall objective ocular signs	8 weeks
overall side-effect scores	8 weeks

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand