A Long Term Study of STN1012600 in Subjects With Open Angle Glaucoma or Ocular Hypertension

Santen Pharmaceutical Co., Ltd.131 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

131

Conditions

Open Angle Glaucoma, Ocular Hypertension

Interventions

STN1012600 ophthalmic solution 0.002%DRUG

1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks

STN1012600 ophthalmic solution 0.002%DRUG

1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks

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

1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks and 1 drop Timolol ophthalmic solution 0.5% twice daily for 52 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (18)

Kitanagoya Eye Clinic

Aichi, Japan

Miyake Eye Hospital

Aichi, Japan

Nagasaka Eye Clinic

Aichi, Japan

Outcomes

Primary Outcomes

Change from baseline in mean diurnal intraocular pressure

Change from baseline in mean diurnal intraocular pressure at each post-baseline visit

Time frame: 52 weeks

Percent change from baseline in mean diurnal intraocular pressure

Percent change from baseline in mean diurnal intraocular pressure at each post-baseline visit

Time frame: 52 weeks

Data from ClinicalTrials.gov

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