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

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ClinicalTrials.gov Identifier: NCT00567918
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : April 4, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Conjunctivitis Drug: FK506 Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients
Study Start Date : May 2004
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
Drug Information available for: Tacrolimus
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
FK506 ophthalmic suspension
Drug: FK506
Ophthalmic suspension
Other Name: tacrolimus


Outcome Measures

Primary Outcome Measures :
  1. Safety [ Time Frame: length of study ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00567918     History of Changes
Other Study ID Numbers: FJ-506D-AC10
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: April 4, 2008
Last Verified: April 2008

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
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action