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

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ClinicalTrials.gov Identifier: NCT00567762
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : February 2004
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1
FK506 ophthalmic suspension
Drug: FK506
Opthalmic suspension
Other Name: tacrolimius
Placebo Comparator: 2
Base of eye drops
Drug: placebo
placebo eye drops



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Subjective symptom score (Visual Analog Scale) [ Time Frame: 4 weeks ]
  3. The improvement rate of subjective symptoms [ Time Frame: 4 weeks ]


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 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

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): 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

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00567762     History of Changes
Other Study ID Numbers: FJ-506D-AC09
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014

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