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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: STN1012600 ophthalmic solution 0.002%
* Drug: STN1012600 ophthalmic solution 0.002%
* Drug: STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: STN1012600 0.002%<br> | Drug: STN1012600 ophthalmic solution 0.002%<br>* 1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks<br>|
| Experimental: Group 2: STN1012600 0.002%<br> | Drug: STN1012600 ophthalmic solution 0.002%<br>* 1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks<br>|
| Experimental: Group 3: STN1012600 0.002% + Timolol 0.5%<br> | Drug: STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean diurnal intraocular pressure | Change from baseline in mean diurnal intraocular pressure at each post-baseline visit | 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 | 52 weeks |