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

February 11, 2010 updated by: Siriraj Hospital

A Double-blind Comparison of 0.1% Tacrolimus Ophthalmic Ointment and 2% Cyclosporine Eye Drops in the Treatment of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall subjective ocular symptom scores
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
overall objective ocular signs
Time Frame: 8 weeks
8 weeks
overall side-effect scores
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Investigators

  • Principal Investigator: Pakit Vichyanond, MD, Faculty of Medicine Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

February 11, 2010

First Submitted That Met QC Criteria

February 11, 2010

First Posted (Estimate)

February 12, 2010

Study Record Updates

Last Update Posted (Estimate)

February 12, 2010

Last Update Submitted That Met QC Criteria

February 11, 2010

Last Verified

June 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fk506vscyclosporine_vkc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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