NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031200106

Registered date:02/09/2020

24 hour intraocular pressure lowering effect of Omidenepag isopropyl (24h-IOP-lowering effect of Omidenepag isopropyl)

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPrimary open angle glaucoma (broad sense) or ocular hypertension
Date of first enrollment27/09/2020
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Intervention(s)Omidenepag isopropyl ophthalmic solution is instilled once daily in one or both eyes at night.

Outcome(s)

Primary OutcomeComparison of Diurnal and Nocturnal mean IOP at Weeks 0 and 4
Secondary OutcomeComparison of IOP at each time point at Weeks 0 and 4 Comparison of 24 hour mean IOP at Weeks 0 and 4 Comparison of IOP fluctuation and standard deviations at Weeks 0 and 4 Comparison of IOP elevation between supine and sitting position at Weeks 0 and 4

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1)Patients with at least one eye of primary open angle glaucoma (broad sense) or ocular hypertension and no prior therapy within the past 4 weeks 2)Patients who are judged by the investigator or subinvestigator to require treatment for primary open angle glaucoma (broad sense) or ocular hypertension
Exclude criteria1)Patients with aphakia or implanted intraocular lens 2)Patients with any corneal abnormality or other disease that may interfere with accurate IOP measurement with a Goldmann applanation tonometer 3)Patients with a history of refractive corneal surgery 4)Patients with corrected visual acuity of 0.6 or less 5)Patients who may have advanced visual field impairment during the study period

Related Information

Contact

Public contact
Name Sasaki Miki
Address Yotsuya MedicalBuilding 3F, 20 Samon-cho, Shinjuku-ku, Tokyo Tokyo Japan 160-0017
Telephone +81-353663006
E-mail m-sasaki@shinanokai.com
Affiliation Shinanozaka Clinic
Scientific contact
Name Shiratori Naka
Address Yotsuya MedicalBuilding 3F, 20 Samon-cho, Shinjuku-ku, Tokyo Tokyo Japan 160-0017
Telephone +81-3-5366-3006
E-mail shiratori@nms.ac.jp
Affiliation Shinanozaka Clinic