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Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

NCT ID: NCT00567918

Last Updated: 2008-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2008-01-31

Brief Summary

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To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis

Detailed Description

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To give a chance of continuous use of 0.1% FK506 ophthalmic suspension to patients with vernal keratoconjunctivitis who were enrolled in the FJ-506D-AC09 study, long-term safety and efficacy were evaluated. Primary efficacy endpoint was the mean change from the baseline (before the treatment) in total score for objective clinical signs.

Conditions

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Keratoconjunctivitis Conjunctivitis

Keywords

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Keratoconjunctivitis Vernal keratoconjunctivitis FK506 Tacrolimus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

FK506 ophthalmic suspension

Group Type EXPERIMENTAL

FK506

Intervention Type DRUG

Ophthalmic suspension

Interventions

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FK506

Ophthalmic suspension

Intervention Type DRUG

Other Intervention Names

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tacrolimus

Eligibility Criteria

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Inclusion Criteria

* Vernal keratoconjunctivitis patients who were enrolled in the FJ-506D-AC09 study
* Patients who wish to receive continuous administration of FK506 ophthalmic suspension

Exclusion Criteria

* Subjects who needed prohibited concomitant therapy at the initiation of the study
* Subjects who needed to wear contact lenses during treatment period on a testing eye
* Subjects with complicating an eye infection
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma Inc.

Principal Investigators

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Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Ehime, , Japan

Site Status

Hokkaido, , Japan

Site Status

Kagoshima, , Japan

Site Status

Kochi, , Japan

Site Status

Miyazaki, , Japan

Site Status

Osaka, , Japan

Site Status

Tochigi, , Japan

Site Status

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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FJ-506D-AC10

Identifier Type: -

Identifier Source: org_study_id