A study of DE-127 ophthalmic solution in subjects with myopia - A Phase II/III
Phase 2
Completed
- Conditions
- Myopia
- Registration Number
- JPRN-jRCT2080224816
- Lead Sponsor
- Santen Pharmaceutical co.,Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 288
Inclusion Criteria
Written informed consent from legally acceptable representative and assent from subject have been obtained.
- Cycloplegic objective spherical equivalent -1.0 to -6.0 D
- Active myopia progression with vision acuity test
Exclusion Criteria
- Patients who previously used contact lenses and/or treatments for reducing myopia progression.
- Patients who previously participated in a clinical trial of DE-127 ophthalmic solution.
- Other patients who are inappropriate as participants in this study in the opinion of the investigator or subinvestigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>The change in objective spherical equivalent
- Secondary Outcome Measures
Name Time Method safety<br>Adverse events