An Open-Label, Long-Term Phase III Study of STN1012600 Ophthalmic Solution Alone and in Combination With Timolol Ophthalmic Solution, in Subjects With Open Angle Glaucoma or Ocular Hypertension (Angel-J2 Study)

Santen Pharmaceutical Co., Ltd.18 sites in 1 country131 target enrollmentAugust 8, 2022

ConditionsOpen Angle Glaucoma, Ocular Hypertension

InterventionsSTN1012600 ophthalmic solution 0.002%STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%

DrugsSTN1012600 ophthalmic solution 0.002%STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%

Overview

Phase: Phase 3
Intervention: STN1012600 ophthalmic solution 0.002%
Conditions: Open Angle Glaucoma, Ocular Hypertension
Sponsor: Santen Pharmaceutical Co., Ltd.
Enrollment: 131
Locations: 18
Primary Endpoint: Change from baseline in mean diurnal intraocular pressure
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate safety and the ocular hypotensive effect of STN1012600 ophthalmic solution 0.002% alone or in combination with Timolol ophthalmic solution 0.5% for 52 weeks in subjects with open angle glaucoma or ocular hypertension.

Registry

clinicaltrials.gov

Start Date

August 8, 2022

End Date

January 30, 2024

Last Updated

last year

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 OAG or OHT in both eyes, or one eye with OAG 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.