24
Participants
Start Date
November 1, 2020
Primary Completion Date
November 30, 2022
Study Completion Date
December 31, 2022
Ripasudil ophthalmic solution 0.4%
"Phase1 A total of three infants will receive ripasudil eye drops(0.4%) once daily for one week, followed by twice-daily drug administration for two weeks. The three infants who participate in Phase1 can continue to receive the eye drop treatment for additional 9 weeks(12 weeks in total)if the investigators determine that there are no safety issues with ripasudil. In addition, a data and safety monitoring board(DSMB)will be held two times to decide whether the new patients can be enrolled into phase1, and also if phase2 can begin.~Phase2:A total of 21 patients will receive ripasudil eye drops(0.4%)twice daily for 12 weeks."
University Hospital of Occupational and Environmental Health, Kitakyushu
Yamaguchi University Hospital, Ube
Kyushu University Hospital, Fukuoka
Kyushu University
OTHER