DE-117B Biological equivalence study
Phase 3
Completed
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Registration Number
- JPRN-jRCT2080225126
- Lead Sponsor
- Santen pharmaceutical co.,ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Must have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
- Corrected visual acuity (CVA) of 0.2 or better in each eye.
Exclusion Criteria
- Females who are pregnant, nursing or planning a pregnancy.
- Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period.
- Use of contact lenses within 2-3 weeks prior to Baseline until end of treatment in either eye
- Aphakia or pseudophakia in either eye
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method bioequivalence<br>Mean diurnal IOP at Week 4 visit
- Secondary Outcome Measures
Name Time Method bioequivalence<br>Mean diurnal IOP at Week 1 visit