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

Tracking Information

First Received Date ^ICMJE

December 3, 2007

Last Updated Date

February 25, 2009

Start Date ^ICMJE

February 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00567762 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Keratoconjunctivitis
Conjunctivitis

Intervention ^ICMJE

Drug: FK506
Drug: placebo

Study Arms / Comparison Groups

Experimental: FK506 ophthalmic suspension
Placebo Comparator: Base of eye drops

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00567762

Responsible Party

Study ID Numbers ^ICMJE

FJ-506D-AC09

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Central Contact

Astellas Pharma Inc

Information Provided By

Astellas Pharma Inc

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP