Primary open-angle glaucoma (broad definition) or ocular hypertension
Conditions
Interventions
One drop of SJP-0125 is instilled into each eye once a day (in the morning) for 1 day.
One drop of 0.1% brimonidine tartrate ophthalmic solution is instilled into each eye once a day (in the morning)
Sponsors
Senju Pharmaceutical Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Written informed consent obtained after adequate explanation on participating the study 2)Japanese male or female aged 20 to 35 years at consent 3)Able and willing to adhere the study instructions to the subjects defined in the protocol and the study schedule 4)IOP >= 10 mmHg and =< 20 mmHg in each eye, and asymmetry of IOP not greater than 5 mmHg
Exclusion criteria
Exclusion criteria: 1)Presence of any disease irrespective of receiving medical treatment 2)History of a serious systemic disease 3)History of a serious psychiatric disorder 4)History of ocular surgery or history of ocular injury considered to be inappropriate to participate in the study 5)History of drug allergy 6)Use of any drugs within 14 days prior to the start of the study treatment 7)Males or females who made blood donation of 400 mL or more within 84 days or 112 days, respectively, prior to the start of the study treatment 8)Participated in any other clinical trial within past 90 days and received any other investigational drug or plans to participate in any other clinical trial during the study 9)Presence of abnormal ophthalmologic findings 10)Anticipated wearing of any contact lenses 11)Best corrected acuity <1.0 12)Body mass index < 18.5 or >= 25.0 13)Females who are pregnant, breastfeeding, or potentially pregnant. Or females who desire to be pregnant or males whose partners desire to be pregnant, or males or females who do not intend to use a reliable means of contraception from consent to the end of the study 14)Prior ocular instillation of SJP-0125
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of SJP-0125 | — |
Countries
Japan
Contacts
Public ContactTakuro Sekiya
Senju Pharmaceutical Co.,Ltd. Clinical Development
Outcome results
None listed