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

Astellas Pharma Inc0 sites52 target enrollmentMay 2004

ConditionsKeratoconjunctivitis Conjunctivitis

InterventionsFK506

DrugsFK506

Overview

Phase: Phase 3
Intervention: FK506
Conditions: Keratoconjunctivitis
Sponsor: Astellas Pharma Inc
Enrollment: 52
Primary Endpoint: Safety
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

January 2008

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Astellas Pharma Inc

Eligibility Criteria

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

Arms & Interventions

1

FK506 ophthalmic suspension

Intervention: FK506

Outcomes

Primary Outcomes

Safety

Time Frame: length of study

Secondary Outcomes

The mean change from the baseline (before the treatment) in total score for objective clinical signs(length of study)
Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign(Length of study)
Subjective symptom score (Visual Analog Scale)(Length of study)
The improvement rate(Length of study)