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

This study has been completed.
Sponsor:
Information provided by:
Siriraj Hospital
ClinicalTrials.gov Identifier:
NCT01068054
First received: February 11, 2010
Last updated: NA
Last verified: June 2003
History: No changes posted
  Purpose

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 Intervention Phase
Keratoconjunctivitis, Vernal
Drug: tacrolimus
Drug: cyclosporins
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Siriraj Hospital:

Primary Outcome Measures:
  • overall subjective ocular symptom scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall objective ocular signs [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • overall side-effect scores [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: June 2003
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068054

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

No publications provided

Responsible Party: Pakit Vichyanond, MD, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT01068054     History of Changes
Other Study ID Numbers: fk506vscyclosporine_vkc
Study First Received: February 11, 2010
Last Updated: February 11, 2010
Health Authority: Thailand: Ethical Committee

Keywords provided by Siriraj Hospital:
vernal keratoconjunctivitis
FK-506
tacrolimus
cyclosporine
children

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Keratoconjunctivitis
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Keratitis
Cyclosporine
Cyclosporins
Ophthalmic Solutions
Tacrolimus
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014