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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00567918

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

6.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis Conjunctivitis	Drug: FK506	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 FK506 ophthalmic suspension	Drug: FK506 Ophthalmic suspension Other Names: tacrolimus

Arm

Intervention/Treatment

Experimental: 1

FK506 ophthalmic suspension

Drug: FK506

Ophthalmic suspension

Other Names:

tacrolimus

Outcome Measures

Primary Outcome Measures

Safety [length of study]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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