Back to results

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

Primary Purpose

Keratoconjunctivitis, Conjunctivitis

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

FK506

About this trial

This is an interventional treatment trial for Keratoconjunctivitis focused on measuring Keratoconjunctivitis, Vernal keratoconjunctivitis, FK506, Tacrolimus

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

FK506 ophthalmic suspension

Outcomes

Primary Outcome Measures

Safety

Secondary Outcome Measures

The mean change from the baseline (before the treatment) in total score for objective clinical signs

Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign

Subjective symptom score (Visual Analog Scale)

The improvement rate

Full Information

NCT ID

NCT00567918

First Posted

December 3, 2007

Last Updated

April 3, 2008

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00567918

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keratoconjunctivitis, Conjunctivitis

Keywords

Keratoconjunctivitis, Vernal keratoconjunctivitis, FK506, Tacrolimus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

FK506 ophthalmic suspension

Intervention Type

Drug

Intervention Name(s)

FK506

Other Intervention Name(s)

tacrolimus

Intervention Description

Ophthalmic suspension

Primary Outcome Measure Information:

Title

Safety

Time Frame

length of study

Secondary Outcome Measure Information:

Title

The mean change from the baseline (before the treatment) in total score for objective clinical signs

Time Frame

length of study

Title

Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign

Time Frame

Length of study

Title

Subjective symptom score (Visual Analog Scale)

Time Frame

Length of study

Title

The improvement rate

Time Frame

Length of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Central Contact

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Study Chair

Facility Information:

City

Ehime

Country

Japan

City

Hokkaido

Country

Japan

City

Kagoshima

Country

Japan

City

Kochi

Country

Japan

City

Miyazaki

Country

Japan

City

Osaka

Country

Japan

City

Tochigi

Country

Japan

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs