A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

Study Overview
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Brief Summary
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Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss. This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension. The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.

Official Title
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A Phase IIb, Randomized, Observer-Masked, Placebo- and Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-126 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

Conditions
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Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution
* Drug: Topical ultra-low dose of DE-126 Ophthalmic Solution
* Drug: Topical low dose of DE-126 Ophthalmic Solution
* Drug: Topical medium dose of DE-126 Ophthalmic Solution
* Drug: Topical high dose of DE-126 Ophthalmic Solution
* Drug: 0.005% Latanoprost Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed written informed consent Diagnosis of POAG or OHT in both eyes 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 90 days prior to Visit 1 (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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (Vehicle of DE-126) followed by high dose of DE-126<br> | Drug: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution<br>* Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks<br>|
| Experimental: Ultra-low dose 0.0005% DE-126<br> | Drug: Topical ultra-low dose of DE-126 Ophthalmic Solution<br>* Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks<br>|
| Experimental: Low dose 0.001% DE-126<br> | Drug: Topical low dose of DE-126 Ophthalmic Solution<br>* Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks<br>|
| Experimental: Medium dose 0.002% DE-126<br> | Drug: Topical medium dose of DE-126 Ophthalmic Solution<br>* Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks<br>|
| Experimental: High dose 0.003% DE-126<br> | Drug: Topical high dose of DE-126 Ophthalmic Solution<br>* Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks<br>|
| Active Comparator: 0.005% Latanoprost<br> | Drug: 0.005% Latanoprost Ophthalmic Solution<br>* 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks<br>* Other names: Xalatan®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure in the Study Eye at Month 3 | Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. | 9:00, 13:00 and 17:00 at Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure in the Study Eye at Week 6 | Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. | 9:00, 13:00 and 17:00 at Week 6 | 
| Intraocular Pressure in the Study Eye at Week 1 and Week 2 | Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. | 9:00, 13:00 and 17:00 at Week 1 and Week 2 | 
| Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject. | Week 1, Week 2, Week 6 and Month 3. | 
| Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject. | Week 1, Week 2, Week 6 and Month 3. | 
| Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit | Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject. | Week 1, Week 2, Week 6 and Month 3. | 
| Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. | 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3. | 
| Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit | Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. | 9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3. | 
| Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit | A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 20%. A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 25%. A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 30%. | WeeK 1, Week 2, Week 6 and Month 3. | 
| Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit | A subject was a responder if the mean diurnal IOP in the study eye was ≤ 18 mmHg. | Week 1, Week 2, Week 6 and Month 3. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma