Back to resultsEfficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)
Primary Purpose
Keratoconjunctivitis, Vernal
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
tacrolimus
cyclosporins
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconjunctivitis, Vernal focused on measuring vernal keratoconjunctivitis, FK-506, tacrolimus, cyclosporine, children
Eligibility 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
Sites / Locations
- Faculty of Medicine Siriraj Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
tacrolimus
cyclosporine
Arm Description
Tacrolimus arm: active 0.1% tacrolimus eye ointment BID + placebo eye drops QID
2% cyclosporine eye drops apply QID + placebo eye ointment apply bid
Outcomes
Primary Outcome Measures
overall subjective ocular symptom scores
Secondary Outcome Measures
overall objective ocular signs
overall side-effect scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01068054
Brief Title
Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)
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 Type
Interventional
2. Study Status
Record Verification Date
June 2003
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Siriraj Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis, Vernal
Keywords
vernal keratoconjunctivitis, FK-506, tacrolimus, cyclosporine, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tacrolimus
Arm Type
Active Comparator
Arm Description
Tacrolimus arm: active 0.1% tacrolimus eye ointment BID + placebo eye drops QID
Arm Title
cyclosporine
Arm Type
Active Comparator
Arm Description
2% cyclosporine eye drops apply QID + placebo eye ointment apply bid
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Intervention Description
0.1% ointment,apply bid, 8 weeks
Intervention Type
Drug
Intervention Name(s)
cyclosporins
Intervention Description
2% eyclosporine eye drops apply 1 drop to each eye QID
Primary Outcome Measure Information:
Title
overall subjective ocular symptom scores
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
overall objective ocular signs
Time Frame
8 weeks
Title
overall side-effect scores
Time Frame
8 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pakit Vichyanond, MD
Organizational Affiliation
Faculty of Medicine Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)
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