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Completed

NCT Number: NCT01068054

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

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.

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Key information

Conditions

Keratoconjunctivitis, Vernal Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

0.1% ointment,apply bid, 8 weeks

cyclosporins

Drug

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

Primary outcomes

  1. overall subjective ocular symptom scores

    Time frame: 8 weeks

Secondary outcomes

  1. overall objective ocular signs

    Time frame: 8 weeks

  2. overall side-effect scores

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Feb 12, 2010
Registry last updated
Feb 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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