Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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Reduction 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 DE-126, ophthalmic solution in subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The IOP will be measured at 3 different times throughout the day, over 4 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, and vital signs. 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, Double-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Conditions
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Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: DE-126 Ophthalmic Solution 0.002% QD
* Drug: Timolol Maleate Ophthalmic Solution 0.5% BID


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been diagnosed of POAG or OHT in both eyes, or one eye with OAG and other with OHT Completed the required wait/washout period Qualifying Day 1 IOP measurement at 3 time-points in both eyes Exclusion Criteria: Females who are pregnant, nursing, or planning a pregnancy Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period. History of ocular surgery specifically intended to lower IOP in either eye. Laser iridotomy in history is allowed Presence of advanced glaucoma in either eye

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DE-126 Opthalmic Solution 0.002% QD and Vehicle QD<br>DE-126 Ophthalmic Solution 0.002% is administered once daily (QD) | Drug: DE-126 Ophthalmic Solution 0.002% QD<br>* DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning<br>|
| Active Comparator: Timolol Maleate Opthalmic Solution 0.5% BID<br>Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID) | Drug: Timolol Maleate Ophthalmic Solution 0.5% BID<br>* Timolol Maleate Ophthalmic Solution BID (morning and evening)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure at Week 2 | Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM). | 08:00, 10:00 and 16:00 at Week 2 | 
| Intraocular Pressure at Week 6 | Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM). | 08:00, 10:00 and 16:00 at Week 6 | 
| Intraocular Pressure at Month 3 | Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM). | 08:00, 10:00 and 16:00 at Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Diurnal Intraocular Pressure at Month 3 | Mean diurnal Intraocular Pressure (IOP) was defined as the mean of the IOP valued at the three schedules timepoints (8:00, 10:00 and 16:00) at that visit for that subject. | Three months | 

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