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

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

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

Study Overview

• Status: Completed
• Conditions: Keratoconjunctivitis; Conjunctivitis
• Intervention / Treatment: Drug: FK506

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Ehime, Japan
  • Hokkaido, Japan
  • Kagoshima, Japan
  • Kochi, Japan
  • Miyazaki, Japan
  • Osaka, Japan
  • Tochigi, Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; FK506 ophthalmic suspension	Drug: FK506; Ophthalmic suspension; Other Names: tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety	length of study

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: December 3, 2007
• First Submitted That Met QC Criteria: December 3, 2007
• First Posted (Estimate): December 5, 2007

Study Record Updates

• Last Update Posted (Estimate): April 4, 2008
• Last Update Submitted That Met QC Criteria: April 3, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: Tacrolimus; FK506; Vernal keratoconjunctivitis; Keratoconjunctivitis
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Keratitis; Corneal Diseases; Conjunctivitis; Conjunctivitis, Allergic; Keratoconjunctivitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: FJ-506D-AC10