Back to resultsPhase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis
Primary Purpose
Keratoconjunctivitis, Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
FK506
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconjunctivitis focused on measuring Keratoconjunctivitis, vernal keratoconjunctivitis, FK506, Tacrolimus
Eligibility Criteria
Inclusion Criteria:
- Vernal keratoconjunctivitis patients diagnosed by "Guideline of diagnosis and treatment of allergic conjunctival disease"
- Patients with type I reactions defined by skin testing, antibody measurement, etc.
- Age over 6 years old
Exclusion Criteria:
- Subjects receiving systemic administration or subconjunctival injection of corticosteroid or immunosuppressants(ophthalmic and systemic medications) within 2-weeks of initiation of the study
- Subjects needed to wear contact lenses during treatment period on a testing eye
- Subjects complicating an eye infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
FK506 ophthalmic suspension
Base of eye drops
Outcomes
Primary Outcome Measures
Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation
Secondary Outcome Measures
Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign
Subjective symptom score (Visual Analog Scale)
The improvement rate of subjective symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00567762
Brief Title
Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis
Official Title
A Randomized, Placebo-controlled, Double-masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis
Detailed Description
0.1% FK506 ophthalmic suspension were administered twice-a-day to patients with vernal keratoconjunctivitis in whom treatment with topical anti-allergic agents had been ineffective. The primary efficacy endpoint was the mean change from the baseline (before the treatment)in total score for objective clinical signs at the final observation. The safety of FK506 ophthalmic suspension was also investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis, Conjunctivitis
Keywords
Keratoconjunctivitis, vernal keratoconjunctivitis, FK506, Tacrolimus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
FK506 ophthalmic suspension
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Base of eye drops
Intervention Type
Drug
Intervention Name(s)
FK506
Other Intervention Name(s)
tacrolimius
Intervention Description
Opthalmic suspension
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo eye drops
Primary Outcome Measure Information:
Title
Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign
Time Frame
Week 1, 2 and 4
Title
Subjective symptom score (Visual Analog Scale)
Time Frame
4 weeks
Title
The improvement rate of subjective symptoms
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Vernal keratoconjunctivitis patients diagnosed by "Guideline of diagnosis and treatment of allergic conjunctival disease"
Patients with type I reactions defined by skin testing, antibody measurement, etc.
Age over 6 years old
Exclusion Criteria:
Subjects receiving systemic administration or subconjunctival injection of corticosteroid or immunosuppressants(ophthalmic and systemic medications) within 2-weeks of initiation of the study
Subjects needed to wear contact lenses during treatment period on a testing eye
Subjects complicating an eye infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Ehime
Country
Japan
City
Hokkaido
Country
Japan
City
Kagoshima
Country
Japan
City
Kochi
Country
Japan
City
Miyazaki
Country
Japan
City
Osaka
Country
Japan
City
Tochigi
Country
Japan
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140570 in the JapicCTI-RNo. field
Learn more about this trial
Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis
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