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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01068054
Recruitment Status : Completed
First Posted : February 12, 2010
Last Update Posted : February 12, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis, Vernal Drug: tacrolimus Drug: cyclosporins Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind Comparison of 0.1% Tacrolimus Ophthalmic Ointment and 2% Cyclosporine Eye Drops in the Treatment of Vernal Keratoconjunctivits (VKC)
Study Start Date : June 2003
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. overall subjective ocular symptom scores [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. overall objective ocular signs [ Time Frame: 8 weeks ]
  2. overall side-effect scores [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01068054

Faculty of Medicine Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Siriraj Hospital
Principal Investigator: Pakit Vichyanond, MD Faculty of Medicine Siriraj Hospital

Responsible Party: Pakit Vichyanond, MD, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University Identifier: NCT01068054     History of Changes
Other Study ID Numbers: fk506vscyclosporine_vkc
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: February 12, 2010
Last Verified: June 2003

Keywords provided by Siriraj Hospital:
vernal keratoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Hypersensitivity, Immediate
Immune System Diseases
Ophthalmic Solutions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants