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

Siriraj Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Keratoconjunctivitis, Vernal

Treatments: Drug: tacrolimus; Drug: cyclosporins

Study type: Interventional

Funder types: Other

Identifiers

NCT01068054

fk506vscyclosporine_vkc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

tacrolimus

Active Comparator group

Description:

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

Treatment:

Drug: tacrolimus

cyclosporine

Active Comparator group

Description:

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

Treatment:

Drug: cyclosporins