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

This study has been completed.
Information provided by:
Astellas Pharma Inc Identifier:
First received: December 3, 2007
Last updated: April 3, 2008
Last verified: April 2008
To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis

Condition Intervention Phase
Drug: FK506
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety [ Time Frame: length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The mean change from the baseline (before the treatment) in total score for objective clinical signs [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Subjective symptom score (Visual Analog Scale) [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • The improvement rate [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: May 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
FK506 ophthalmic suspension
Drug: FK506
Ophthalmic suspension
Other Name: tacrolimus

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.

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00567918

Ehime, Japan
Hokkaido, Japan
Kagoshima, Japan
Kochi, Japan
Miyazaki, Japan
Osaka, Japan
Tochigi, Japan
Tokyo, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Central Contact Astellas Pharma Inc
  More Information

Responsible Party: Director, Astellas Pharma Inc. Identifier: NCT00567918     History of Changes
Other Study ID Numbers: FJ-506D-AC10 
Study First Received: December 3, 2007
Last Updated: April 3, 2008
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Vernal keratoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Corneal Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on April 27, 2016