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)

101260005LT

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.

2022-08-09

2023-04-18

2023-04-18

Completed

Early phase I

325

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 325, 'type': 'ACTUAL'}}

2023-12-05