Keratoconjunctivitis, Conjunctivitis
Conditions
Keywords
Keratoconjunctivitis, Vernal keratoconjunctivitis, FK506, Tacrolimus
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.
Interventions
DRUGFK506
Ophthalmic suspension
Sponsors
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | length of study |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed