NCT00567918

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2004

Typical duration for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

April 4, 2008

Status Verified

April 1, 2008

Enrollment Period

3.7 years

First QC Date

December 3, 2007

Last Update Submit

April 3, 2008

Conditions

KeratoconjunctivitisConjunctivitis

Keywords

KeratoconjunctivitisVernal keratoconjunctivitisFK506Tacrolimus

Outcome Measures

Primary Outcomes (1)

  • Safety

    length of study

Secondary Outcomes (4)

  • 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

Study Arms (1)

1

EXPERIMENTAL

FK506 ophthalmic suspension

Drug: FK506

Interventions

FK506DRUG

Ophthalmic suspension

Also known as: tacrolimus
1

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Ehime, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Kochi, Japan

Location

Unknown Facility

Miyazaki, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tochigi, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

KeratoconjunctivitisConjunctivitisConjunctivitis, Allergic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye DiseasesKeratitisCorneal DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 5, 2007

Study Start

May 1, 2004

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

April 4, 2008

Record last verified: 2008-04

Locations

JP(8)