Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00567762
First received: December 3, 2007
Last updated: August 29, 2014
Last verified: August 2014
  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:


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
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: 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

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00567762     History of Changes
Other Study ID Numbers: FJ-506D-AC09
Study First Received: December 3, 2007
Last Updated: August 29, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Keratoconjunctivitis
vernal keratoconjunctivitis
FK506
Tacrolimus

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

ClinicalTrials.gov processed this record on October 20, 2014