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 |
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Health condition(s) or Problem(s) studied | Primary open angle glaucoma (broad sense) or ocular hypertension |
Date of first enrollment | 27/09/2020 |
Target sample size | 30 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Intervention(s)Omidenepag isopropyl ophthalmic solution is instilled once daily in one or both eyes at night. |
Outcome(s)
Primary Outcome | Comparison of Diurnal and Nocturnal mean IOP at Weeks 0 and 4 |
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Secondary Outcome | Comparison 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 |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1)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 criteria | 1)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
Primary Sponsor | Naka Shiratori |
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Secondary Sponsor | Kenji Nakamoto,Santen Pharmaceutical Co., Ltd. |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Sasaki Miki |
Address | Yotsuya MedicalBuilding 3F, 20 Samon-cho, Shinjuku-ku, Tokyo Tokyo Japan 160-0017 |
Telephone | +81-353663006 |
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 |
shiratori@nms.ac.jp | |
Affiliation | Shinanozaka Clinic |