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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: December 3, 2007
Last updated: August 29, 2014
Last verified: August 2014
To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis

Condition Intervention Phase
Drug: FK506
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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.

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 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
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Please refer to this study by its identifier: NCT00567762

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

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00567762     History of Changes
Other Study ID Numbers: FJ-506D-AC09
Study First Received: December 3, 2007
Last Updated: August 29, 2014

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 April 26, 2017