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

• Status: Recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Pharmaceutical Co., Ltd.
• Treatments: Latanoprost; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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.