Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis
- Registration Number
- NCT00567918
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 FK506 FK506 ophthalmic suspension
- Primary Outcome Measures
Name Time Method Safety length of study
- Secondary Outcome Measures
Name Time Method The mean change from the baseline (before the treatment) in total score for objective clinical signs length of study Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign Length of study Subjective symptom score (Visual Analog Scale) Length of study The improvement rate Length of study