NCT00567762

Brief Summary

To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2004

Shorter than P25 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

February 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
3.3 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
Last Updated

September 1, 2014

Status Verified

August 1, 2014

First QC Date

December 3, 2007

Last Update Submit

August 29, 2014

Conditions

KeratoconjunctivitisConjunctivitis

Keywords

Keratoconjunctivitisvernal keratoconjunctivitisFK506Tacrolimus

Outcome Measures

Primary Outcomes (1)

  • Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation

    4 weeks

Secondary Outcomes (3)

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

    Week 1, 2 and 4

  • Subjective symptom score (Visual Analog Scale)

    4 weeks

  • The improvement rate of subjective symptoms

    4 weeks

Study Arms (2)

1

EXPERIMENTAL

FK506 ophthalmic suspension

Drug: FK506

2

PLACEBO COMPARATOR

Base of eye drops

Drug: placebo

Interventions

FK506DRUG

Opthalmic suspension

Also known as: tacrolimius
1
placeboDRUG

placebo eye drops

2

Eligibility Criteria

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

You may qualify if:

  • Vernal keratoconjunctivitis patients diagnosed by "Guideline of diagnosis and treatment of allergic conjunctival disease"
  • Patients with type I reactions defined by skin testing, antibody measurement, etc.
  • Age over 6 years old

You may not qualify if:

  • Subjects receiving systemic administration or subconjunctival injection of corticosteroid or immunosuppressants(ophthalmic and systemic medications) within 2-weeks of initiation of the study
  • Subjects needed to wear contact lenses during treatment period on a testing eye
  • Subjects 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
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 5, 2007

Study Start

February 1, 2004

Study Completion

September 1, 2004

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

JP(8)