Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis - Tabular View

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Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

This study has been completed.

Study NCT00567762. Last updated on December 3, 2007. Information provided by Astellas Pharma Inc

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

Official Title ^†

A Randomized, Placebo-Controlled, Double-Masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis

Brief Summary

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

Detailed Description

0.1% FK506 ophthalmic suspension were administered twice-a-day to patients with vernal keratoconjunctivitis in whom treatment with topical anti-allergic agents had been ineffective. The primary efficacy endpoint was the mean change from the baseline (before the treatment)in total score for objective clinical signs at the final observation. The safety of FK506 ophthalmic suspension was also investigated.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation [ Time Frame: 4 weeks ]

Secondary Outcome Measure ^†

Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign [ Time Frame: Week 1, 2 and 4 ]
Subjective symptom score (Visual Analog Scale) [ Time Frame: 4 weeks ]
The improvement rate of subjective symptoms [ Time Frame: 4 weeks ]

Condition ^†

Keratoconjunctivitis
Conjunctivitis

Intervention ^†

Drug: FK506
Drug: placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

February 2004

Completion Date

September 2004

Eligibility Criteria ^†

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

6 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Administrative Information Fields

NCT ID ^†

NCT00567762

Organization ID

FJ-506D-AC09

Secondary IDs ^††

Study Sponsor ^†

Astellas Pharma Inc

Collaborators ^††

Investigators ^†

Study Chair:

Central Contact

Astellas Pharma Inc

Information Provided By

Astellas Pharma Inc

Verification Date

December 2007

First Received Date ^†

December 3, 2007

Last Updated Date

December 3, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.