JPRN-jRCT2031210122CompletedPhase 3
A Phase 3, double-masked, randomized, multi-center, placebo-controlled, parallel-group, 4-week study evaluating the efficacy and safety of 0.02% STN1013900 ophthalmic solution compared to its vehicle under concomitant use of Latanoprost ophthalmic solution 0.005% in subjects with primary open angle glaucoma or ocular hypertension
Sakamoto Kayoko0 sites234 target enrollmentStarted: May 31, 2021Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 234
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •20 years of age or older
- •Diagnosis of POAG or OHT in both eyes
- •Best-corrected visual acuity (BCVA) +0.7 log MAR or better (>= 20/100 Snellen or >= 0.20 in decimal unit) in each eye
- •Willingness and ability to give signed informed consent and follow study instructions
Exclusion Criteria
- •Ophthalmic:
- •Clinically significant ocular disease
- •Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
- •Previous glaucoma intraocular surgery
- •Refractive surgery in either eye
- •Ocular trauma
- •Ocular infection
- •Any corneal disease
- •Known hypersensitivity to any component of the study drugs, or to topical anesthetic
- •Clinically significant systemic disease
- •Participation in any investigational study within 30 days prior to screening
- •Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
Investigators
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