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.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00567918
First received: December 3, 2007
Last updated: April 3, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Keratoconjunctivitis
Conjunctivitis
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567918

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

No publications provided

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov 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:
Keratoconjunctivitis
Vernal keratoconjunctivitis
FK506
Tacrolimus

Additional relevant MeSH terms:
Conjunctivitis
Keratoconjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014