Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6

Study Overview
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Brief Summary
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This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their current topical IOP lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up to 6 weeks. Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either: DE-117 ophthalmic solution 0.002% QD (Once Daily) DE-117 ophthalmic solution 0.002% BID (Twice Daily) This study will consist of a screening period of up to 35 days including a washout period of up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.

Official Title
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A Randomized, Double-Masked, Parallel-Group, Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension SPECTRUM 6 Study.

Conditions
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Primary Open-angle Glaucoma and Ocular Hypertension

Intervention / Treatment
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* Drug: DE-117 Ophthalmic Solution QD
* Drug: DE-117 Ophthalmic Solution BID


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed written informed consent Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT. Qualifying corrected visual acuity in each eye Qualifying central corneal thickness in each eye Qualifying Day 1 IOP measurement at 3 time-points in both eyes Qualifying Anterior chamber angle Exclusion Criteria: History of ocular surgery specifically intended to lower IOP Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period Advanced glaucoma in either eye Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry Any ocular surgery or ocular laser treatment within 180 days prior to Screening and throughout the study in either eye Females who are pregnant, nursing, or planning a pregnancy

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug Arm: DE-117 QD<br>DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD | Drug: DE-117 Ophthalmic Solution QD<br>* DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye<br>|
| Experimental: Test Arm: DE-117 BID<br>DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00) | Drug: DE-117 Ophthalmic Solution BID<br>* DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) at Week 2 | Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg). | 08:00 at week 2 | 
| Intraocular Pressure (IOP) at Week 2 | Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg). | 12:00 at week 2 | 
| Intraocular Pressure (IOP) at Week 2 | Intraocular pressure (IOP), the fluid pressure inside the eye, was mea... | 16:00 at week 2 | 
| Intraocular Pressure (IOP) at Week 6 | Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg). | 08:00 at week 6 | 
| Intraocular Pressure (IOP) at Week 6 | Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg). | 12:00 at week 6 | 
| Intraocular Pressure (IOP) at Week 6 | Intraocular pressure (IOP), the fluid pressure inside the eye, was mea... | 16:00 at week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Diurnal Intraocular Pressure (IOP) | Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg). | 6 weeks |