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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| - UF-021 | Experimental | UF-021 is experimental code for isopropyl unoprostone |
|
| - Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UF-021 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the value of the mean retinal sensitivity at four central points through HFA (10-2) | baseline and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| - 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) | baseline and 1 year | |
| - Changes in the value of the ETDRS visual acuity | baseline and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
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| Drug |
|
| - Changes in the VFQ-25 (composite 8) value | baseline and 1 year |
| - Changes in the Goldmann visual field area within V4e isopter | baseline and 1 year |
| - Changes in the value of retinal thickness through OCT | baseline and 1 year |
| Hirosaki |
| Aomori |
| Japan |
| Chiba | Chiba | Japan |
| Matsuyama | Ehime | Japan |
| Fukuoka | Fukuoka | Japan |
| Maebashi | Gunma | Japan |
| Kure | Hiroshima | Japan |
| Sapporo | Hokkaido | Japan |
| Kobe | Hyōgo | Japan |
| Mito | Ibaraki | Japan |
| Morioka | Iwate | Japan |
| Kumamoto | Kumamoto | Japan |
| Kyoto | Kyoto | Japan |
| Tsu | Mie-ken | Japan |
| Sendai | Miyagi | Japan |
| Miyakonojō | Miyazaki | Japan |
| Miyazaki | Miyazaki | Japan |
| Beppu | Oita Prefecture | Japan |
| Okayama | Okayama-ken | Japan |
| Tamano | Okayama-ken | Japan |
| Osaka | Osaka | Japan |
| Sayama | Osaka | Japan |
| Izumo | Shimane | Japan |
| Hamamatsu | Shizuoka | Japan |
| Ohtawara | Tochigi | Japan |
| Tokushima | Tokushima | Japan |
| Bunkyo-ku | Tokyo | Japan |
| Chiyoda-ku | Tokyo | Japan |
| Itabashi-ku | Tokyo | Japan |
| Minato-ku | Tokyo | Japan | Japan |
| Mitaka | Tokyo | Japan |
| Toyama | Toyama | Japan |
| Wakayama | Wakayama | Japan |
| Chūō | Yamanashi | Japan |
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C072630 | isopropyl unoprostone |
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