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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | Experimental | DE-126 Ophthalmic Solution 0.002% is administered once daily (QD) |
|
| Timolol Maleate Opthalmic Solution 0.5% BID | Active Comparator | Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-126 Ophthalmic Solution 0.002% QD | Drug | DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | 85224 | United States | ||
| Arizona Glaucoma Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40043909 | Derived | Wirta DL, El-Harazi SM, Tepedino ME, Bacharach J. Sepetaprost 0.002% Noninferiority vs. Timolol 0.5% in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: ANGEL-2. Ophthalmol Glaucoma. 2025 Jul-Aug;8(4):384-392. doi: 10.1016/j.ogla.2025.02.004. Epub 2025 Mar 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Timolol Maleate Opthalmic Solution 0.5% BID | Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID) Timolol Maleate Ophthalmic Solution 0.5% BID: Timolol Maleate Ophthalmic Solution BID (morning and evening) |
| FG001 | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 18, 2021 | Dec 6, 2022 |
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| Timolol Maleate Ophthalmic Solution 0.5% BID | Drug | Timolol Maleate Ophthalmic Solution BID (morning and evening) |
|
| Phoenix |
| Arizona |
| 85050 |
| United States |
| Walman Eye Center | Sun City | Arizona | 85351-3019 | United States |
| Global Research Management | Glendale | California | 91204-2569 | United States |
| Premiere Practice Management | Los Angeles | California | 90013 | United States |
| North Valley Eye Medical Group | Mission Hills | California | 91342 | United States |
| The Eye Research Foundation | Newport Beach | California | 92663-3642 | United States |
| University of California, Los Angeles, Doheny Eye Centers | Pasadena | California | 91105 | United States |
| North Bay Eye Associates, Inc | Petaluma | California | 94954 | United States |
| Sacramento Eye Consultants | Sacramento | California | 95815-4605 | United States |
| University of Colorado, Dept. of Opthamology | Aurora | Colorado | 80045 | United States |
| Hernando Eye Institute | Brooksville | Florida | 34613-6065 | United States |
| Eye Associates of Fort Myers | Fort Myers | Florida | 33901-9311 | United States |
| Levenson Eye Associates | Jacksonville | Florida | 32204 | United States |
| Mayo Clinic, Dept. of Opthamology | Jacksonville | Florida | 32224 | United States |
| Bowden Eye & Associates | Jacksonville | Florida | 32258 | United States |
| Shettle Eye Research | Largo | Florida | 33773 | United States |
| Dixophthal PC dba Dixon Eye Care | Albany | Georgia | 31701-2363 | United States |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | United States |
| Coastal Research Associates | Roswell | Georgia | 30076 | United States |
| Clinical Eye Research of Boston, LLC | Winchester | Massachusetts | 01890 | United States |
| Nevada Eye Care Professionals | Las Vegas | Nevada | 89119 | United States |
| AdvanceMed Clinical Research-Las Vegas | Las Vegas | Nevada | 89123-2810 | United States |
| Northern New Jersey Eye Institute | South Orange | New Jersey | 07079-1855 | United States |
| Rochester Ophthalmological Group, P.C. | Rochester | New York | 14618 | United States |
| Duke Eye Center | Durham | North Carolina | 27705 | United States |
| Wake Forest Health Network Ophthamology - Oak Hollow | High Point | North Carolina | 27262-7612 | United States |
| Vance Thompson Vision - ND | West Fargo | North Dakota | 58078 | United States |
| Apex Eye Clinical Research, LLC | Cincinnati | Ohio | 45242 | United States |
| Office of Mark J. Weiss MD | Tulsa | Oklahoma | 74104-5300 | United States |
| Scott & Christie and Associates PC | Cranberry Township | Pennsylvania | 16066-6412 | United States |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701-7374 | United States |
| University Eye Specialists | Maryville | Tennessee | 37803-6100 | United States |
| VRF Eye Specialty Group | Memphis | Tennessee | 38120-9411 | United States |
| Glaucoma Associates of Texas | Dallas | Texas | 75231-2168 | United States |
| The Cataract and Glaucoma Center | El Paso | Texas | 79902 | United States |
| DCT- Shah Research LLC dba Discovery Clinical Trials | Mission | Texas | 78572-2425 | United States |
| San Antonio Eye Center | San Antonio | Texas | 78215-1936 | United States |
| R and R Eye Research LLC | San Antonio | Texas | 78229-3539 | United States |
| Stacy R. Smith M.D. P.C. | Salt Lake City | Utah | 84117-5209 | United States |
DE-126 Ophthalmic Solution 0.002% is administered once daily (QD) DE-126 Ophthalmic Solution 0.002% QD: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Timolol Maleate Opthalmic Solution 0.5% BID | Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID) Timolol Maleate Ophthalmic Solution 0.5% BID: Timolol Maleate Ophthalmic Solution BID (morning and evening) |
| BG001 | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | DE-126 Ophthalmic Solution 0.002% is administered once daily (QD) DE-126 Ophthalmic Solution 0.002% QD: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study. | Posted | Least Squares Mean | Standard Error | mmHg | 08:00, 10:00 and 16:00 at Week 2 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | 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). | The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study. | Posted | Least Squares Mean | Standard Error | mmHg | 08:00, 10:00 and 16:00 at Week 6 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | 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). | The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study. | Posted | Least Squares Mean | Standard Error | mmHg | 08:00, 10:00 and 16:00 at Month 3 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study. | Posted | Least Squares Mean | Standard Error | mmHg | Three months |
|
|
From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Timolol Maleate Opthalmic Solution 0.5% BID | Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID) Timolol Maleate Ophthalmic Solution 0.5% BID: Timolol Maleate Ophthalmic Solution BID (morning and evening) | 0 | 160 | 3 | 160 | 34 | 160 |
| EG001 | DE-126 Opthalmic Solution 0.002% QD and Vehicle QD | DE-126 Ophthalmic Solution 0.002% is administered once daily (QD) DE-126 Ophthalmic Solution 0.002% QD: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning | 0 | 161 | 1 | 161 | 38 | 161 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Sternal Fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Eyelash thickening | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Eyelid margin crusting | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Scintillating scotoma | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Anterior chamber cell | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Anterior chamber flare | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Macular fibrosis | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Instillation site pain | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Instillation site pruritus | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Limb fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Vital dye staining cornea present | Investigations | MedDRA (23.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Lower respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
| |
| Madarosis | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of R&D Quality Management | Santen Inc | 15106851794 | evelyn.chikere@santen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2021 | Dec 1, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
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| Male |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
|
| Multiple |
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| 16:00 |
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