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

NCT ID: NCT00567762

Last Updated: 2014-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2004-09-30

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.

Conditions

Keratoconjunctivitis; Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

FK506 ophthalmic suspension

Group Type: EXPERIMENTAL

FK506

Intervention Type: DRUG

Opthalmic suspension

2

Base of eye drops

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo eye drops

Interventions

FK506

Opthalmic suspension

Intervention Type: DRUG

placebo

placebo eye drops

Intervention Type: DRUG

Other Intervention Names

tacrolimius

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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

Ehime, , Japan

Hokkaido, , Japan

Kagoshima, , Japan

Kochi, , Japan

Miyazaki, , Japan

Osaka, , Japan

Tochigi, , Japan

Tokyo, , Japan

Countries

Japan

Other Identifiers

FJ-506D-AC09

Identifier Type: -

Identifier Source: org_study_id