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OpenTrials
Completed

NCT Number: NCT00567918

Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

To investigate the long-term efficacy and safety of FK506 ophthalmic suspension 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

To give a chance of continuous use of 0.1% FK506 ophthalmic suspension to patients with vernal keratoconjunctivitis who were enrolled in the FJ-506D-AC09 study, long-term safety and efficacy were evaluated. Primary efficacy endpoint was the mean change from the baseline (before the treatment) in total score for objective clinical signs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Vernal keratoconjunctivitis patients who were enrolled in the FJ-506D-AC09 study
  • Patients who wish to receive continuous administration of FK506 ophthalmic suspension

Exclusion criteria

  • Subjects who needed prohibited concomitant therapy at the initiation of the study
  • Subjects who needed to wear contact lenses during treatment period on a testing eye
  • Subjects with complicating an eye infection

Treatment and study plan

FK506

Drug

Ophthalmic suspension

Other names: tacrolimus

Primary outcomes

  1. Safety

    Time frame: length of study

Secondary outcomes

  1. The mean change from the baseline (before the treatment) in total score for objective clinical signs

    Time frame: length of study

  2. Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign

    Time frame: Length of study

  3. Subjective symptom score (Visual Analog Scale)

    Time frame: Length of study

  4. The improvement rate

    Time frame: Length of study

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Dec 5, 2007
Registry last updated
Apr 4, 2008

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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