K-115 clinical pharmacology study
Phase 3
- Conditions
- healthy volunteers
- Registration Number
- JPRN-jRCT2080221879
- Lead Sponsor
- Kowa Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
1. healthy Japanese male
Exclusion Criteria
1.Patients whose refractive error is below -8 diopter.
2.Patients who had undergone ocular surgery
3.Patients thought to wear contact lenses during this trial
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy :MBR<br>Safety :Adverse event (AE) and adverse drug reaction (ADR)<br><br>Efficacy :Change from baseline in MBR<br>Safety :Incidence of AE and ADR
- Secondary Outcome Measures
Name Time Method Efficacy :IOP, etc<br>Safety :Ophthalmologic examination, etc<br><br>Efficacy : Change from baseline in IOP<br>Safety :Change from baseline in ophthalmologic examination, etc