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

Astellas Pharma Inc56 enrolled

Overview

To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Keratoconjunctivitis Conjunctivitis

Interventions

FK506DRUG

Opthalmic suspension

placeboDRUG

placebo eye drops

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Ehime, Japan

Unnamed facility

Hokkaido, Japan

Unnamed facility

Kagoshima, Japan

Unnamed facility

Kochi, Japan

Unnamed facility

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

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

Subjective symptom score (Visual Analog Scale)

Time frame: 4 weeks

The improvement rate of subjective symptoms

Time frame: 4 weeks

Data from ClinicalTrials.gov

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