A phase I clinical pharmacology study of SJP-0125
- Conditions
- Primary open-angle glaucoma (broad definition) or ocular hypertension
- Registration Number
- JPRN-UMIN000031296
- Lead Sponsor
- Senju Pharmaceutical Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method