A Randomized, Placebo-controlled, Double-masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis
Overview
- Phase
- Phase 3
- Intervention
- FK506
- Conditions
- Keratoconjunctivitis
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 56
- Primary Endpoint
- Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
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
Arms & Interventions
1
FK506 ophthalmic suspension
Intervention: FK506
2
Base of eye drops
Intervention: placebo
Outcomes
Primary Outcomes
Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation
Time Frame: 4 weeks
Secondary Outcomes
- The improvement rate of subjective symptoms(4 weeks)
- Subjective symptom score (Visual Analog Scale)(4 weeks)
- Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign(Week 1, 2 and 4)