Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

Phase 3

Completed

• Conditions: Conjunctivitis; Keratoconjunctivitis
• Interventions: Drug: FK506; Drug: placebo

• Registration Number: NCT00567762
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2004-02
• Study Completion: 2004-09
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-05
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-29
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	FK506	FK506 ophthalmic suspension
2	placebo	Base of eye drops

Primary Outcome Measures

Name	Time	Method
Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation	4 weeks

Secondary Outcome Measures

Name	Time	Method
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