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Efficacy and Safety Study of 0.002% STN1013900 ophthalmic solution under concomitant use of Latanoprost ophthalmic solution 0.005% in subjects with primary open angle glaucoma or ocular hypertension

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031210122
Enrollment
234
Registered
2021-05-31
Start date
2021-07-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary open angle glaucoma (POAG) or ocular hypertension (OHT)

Interventions

STN1013900 Arm: 1 drop 0.02% STN1013900 once daily and 1 drop 0.005% Latanoprost Vehicle Arm: 1 drop vehicle once daily and 1 drop 0.005% Latanoprost

Sponsors

Sakamoto Kayoko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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 Systemic: 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

Design outcomes

Primary

MeasureTime frame
Mean diurnal IOP at Week 4

Contacts

Public ContactKayoko Sakamoto

Santen pharmaceutical co.,ltd

clinical@santen.co.jp+81-6-4802-9341

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026