A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1012600 Ophthalmic Solution 0.002% Compared With Latanoprost 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (Angel-J1 Study)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05495061

Enrollment

325

Registered

2022-08-10

Start date

2022-08-09

Completion date

2023-04-18

Last updated

2023-12-05

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

Conditions

Primary Open Angle Glaucoma, Ocular Hypertension

Brief summary

To investigate whether the IOP lowering efficacy of STN1012600 ophthalmic solution 0.002% is non-inferior to that of latanoprost 0.005% in subjects with POAG or OHT after treatment for 4 weeks.

Interventions

DRUGSTN1012600 ophthalmic solution 0.002%

1 drop STN1012600 ophthalmic solution 0.002% once daily for 3 months

DRUGLatanoprost ophthalmic solution 0.005%

1 drop Latanoprost ophthalmic solution 0.005% once daily for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years of age or older. * Diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT. * Corrected Visual Acuity of +0.60 logMAR (Decimal visual acuity 0.3) or better in each eye.

Exclusion criteria

* Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids in either eye. * History of severe ocular trauma in either eye. * Any condition that prevents clear visualization of the fundus in either eye. * Known allergy, hypersensitivity or contraindications to any components of the study medications or other study related procedures/medications. * History of ocular surgery specifically intended to lower IOP in either eye. * History of keratorefractive surgery in either eye. * Females who are pregnant, nursing, or planning a pregnancy. * Subjects with known or suspected drug or alcohol abuse. * Participation in other investigational drugs or device clinical trials within 30 days prior to Screening. * Any decision by the Investigator to terminate a subject in screening or declare any subject ineligible for any sound medical reason.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in mean diurnal intraocular pressure	4 weeks	Change from baseline in mean diurnal intraocular pressure at Week 4

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026