This study is a multicenter trial performed in Japan, consisting of a comparative study period and a continuous administration period. Effect of 0.15% UF-021 eye drops on improvement in central retinal sensitivity with HFA will be verified in 52 weeks comparative study period by a placebo-controlled, double-masked study in patients with retinitis pigmentosa. The safety of same eye drops will also be examined in 52 weeks continuous administration period, in all the patients who completed the comparative study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Changes in the value of the mean retinal sensitivity at four central points through HFA (10-2)
Time frame: baseline and 1 year
- Changes in the value of the retinal sensitivity through HFA (10-2) (MD value, mean retinal sensitivity at 12 central points /24 central points /68 central points)
Time frame: baseline and 1 year
- Changes in the value of the ETDRS visual acuity
Time frame: baseline and 1 year
- Changes in the VFQ-25 (composite 8) value
Time frame: baseline and 1 year
- Changes in the Goldmann visual field area within V4e isopter
Time frame: baseline and 1 year
- Changes in the value of retinal thickness through OCT
Time frame: baseline and 1 year
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Hirosaki, Aomori, Japan
Unnamed facility
Chiba, Chiba, Japan
Unnamed facility
Matsuyama, Ehime, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Maebashi, Gunma, Japan
Unnamed facility
Kure, Hiroshima, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Mito, Ibaraki, Japan
...and 24 more locations