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

NCT ID: NCT01068054

Last Updated: 2010-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2005-05-31

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.

Conditions

Keratoconjunctivitis, Vernal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

tacrolimus

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

Group Type: ACTIVE_COMPARATOR

tacrolimus

Intervention Type: DRUG

0.1% ointment,apply bid, 8 weeks

cyclosporine

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

Group Type: ACTIVE_COMPARATOR

cyclosporins

Intervention Type: DRUG

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

Interventions

tacrolimus

0.1% ointment,apply bid, 8 weeks

Intervention Type: DRUG

cyclosporins

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

Intervention Type: DRUG

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siriraj Hospital

OTHER

Sponsor Role: lead

Responsible Party

Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University

Principal Investigators

Pakit Vichyanond, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

Faculty of Medicine Siriraj Hospital

Bangkok, Bangkok, Thailand

Countries

Thailand

Other Identifiers

fk506vscyclosporine_vkc

Identifier Type: -

Identifier Source: org_study_id