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)

Santen Pharmaceutical Co., Ltd.44 sites in 1 country325 target enrollmentAugust 9, 2022

ConditionsPrimary Open Angle Glaucoma, Ocular Hypertension

InterventionsSTN1012600 ophthalmic solution 0.002%Latanoprost ophthalmic solution 0.005%

DrugsSTN1012600 ophthalmic solution 0.002%Latanoprost ophthalmic solution 0.005%

Overview

Phase: Phase 3
Intervention: STN1012600 ophthalmic solution 0.002%
Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
Sponsor: Santen Pharmaceutical Co., Ltd.
Enrollment: 325
Locations: 44
Primary Endpoint: Change from baseline in mean diurnal intraocular pressure
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 9, 2022

End Date

April 18, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Santen Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility 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.