To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Ophthalmic suspension
Unnamed facility
Ehime, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kagoshima, Japan
Unnamed facility
Kochi, Japan
Unnamed facility
Safety
Time frame: length of study
The mean change from the baseline (before the treatment) in total score for objective clinical signs
Time frame: length of study
Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign
Time frame: Length of study
Subjective symptom score (Visual Analog Scale)
Time frame: Length of study
The improvement rate
Time frame: Length of study
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Miyazaki, Japan
Unnamed facility
Osaka, Japan
Unnamed facility
Tochigi, Japan
Unnamed facility
Tokyo, Japan