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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: 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 ]

Secondary Outcome Measures:
  • The mean change from the baseline (before the treatment) in total score for objective clinical signs [ Time Frame: length of study ]
  • Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign [ Time Frame: Length of study ]
  • Subjective symptom score (Visual Analog Scale) [ Time Frame: Length of study ]
  • The improvement rate [ Time Frame: Length of study ]

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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Keywords provided by Astellas Pharma Inc:
Vernal keratoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Hypersensitivity, Immediate
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017