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Phase III 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:
NCT00567762
First received: December 3, 2007
Last updated: February 25, 2009
Last verified: December 2007
History of Changes
  Purpose

To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis


Condition Intervention Phase
Keratoconjunctivitis
Conjunctivitis
 Drug: FK506
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis

Resource links provided by NLM:

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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign [ Time Frame: Week 1, 2 and 4 ]
  • Subjective symptom score (Visual Analog Scale) [ Time Frame: 4 weeks ]
  • The improvement rate of subjective symptoms [ Time Frame: 4 weeks ]

Enrollment: 56
Study Start Date: February 2004
Study Completion Date: September 2004
Arms Assigned Interventions
Experimental: 1
FK506 ophthalmic suspension
 Drug: FK506
Opthalmic suspension
Other Name: tacrolimius
Placebo Comparator: 2
Base of eye drops
 Drug: placebo
placebo eye drops

Detailed Description:

0.1% FK506 ophthalmic suspension were administered twice-a-day to patients with vernal keratoconjunctivitis in whom treatment with topical anti-allergic agents had been ineffective. The primary efficacy endpoint was the mean change from the baseline (before the treatment)in total score for objective clinical signs at the final observation. The safety of FK506 ophthalmic suspension was also investigated.

  Eligibility

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

Inclusion Criteria:

  • Vernal keratoconjunctivitis patients diagnosed by "Guideline of diagnosis and treatment of allergic conjunctival disease"
  • Patients with type I reactions defined by skin testing, antibody measurement, etc.
  • Age over 6 years old

Exclusion Criteria:

  • Subjects receiving systemic administration or subconjunctival injection of corticosteroid or immunosuppressants(ophthalmic and systemic medications) within 2-weeks of initiation of the study
  • Subjects needed to wear contact lenses during treatment period on a testing eye
  • Subjects complicating an eye infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567762

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

ClinicalTrials.gov Identifier: NCT00567762     History of Changes
Other Study ID Numbers: FJ-506D-AC09
Study First Received: December 3, 2007
Last Updated: February 25, 2009
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 May 22, 2013