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Completed

NCT Number: NCT00567762

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

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

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Key information

Conditions

Keratoconjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Corneal Diseases Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Keratitis

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ehime, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FK506

Drug

Opthalmic suspension

Other names: tacrolimius

Placebo

Drug

placebo eye drops

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Randomized, Placebo-controlled, Double-masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis

Important dates

Study start
2004
Study completion
2004
First posted
Dec 5, 2007
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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