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This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of 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 baseline will be randomized to receive double-masked treatment for 3 months.
Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DE-117 Ophthalmic Solution | Experimental | Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months |
|
| Timolol Maleate Ophthalmic Solution 0.5% | Active Comparator | Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-117 Ophthalmic Solution | Drug | Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) at Week 1 | Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. | 08:00, 10:00 and 16:00 at Week 1 |
| Intraocular Pressure (IOP) at Week 6 | Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. | 08:00, 10:00 and 16:00 at Week 6 |
| Intraocular Pressure (IOP) at Month 3 | Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. | 08:00, 10:00 and 16:00 at Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint) | To determine if the mean diurnal IOP reduction with DE-117 ophthalmic solution 0.002% is superior to that of Timolol Maleate ophthalmic solution 0.5% at Month 3 in subjects with OAG or OHT. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at Month 3. | Month 3 |
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Inclusion Criteria:
• glaucoma or ocular hypertension
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | 85224 | United States | ||
| M & M Eye Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) | DE-117 0.002% QD in the evening (20:00) and vehicle QD in the morning (08:00). |
| FG001 | Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) |
| 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 | Jul 13, 2018 | Jun 26, 2023 |
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| Timolol Maleate Ophthalmic Solution 0.5% | Drug | Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months |
|
| Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) | Intraocular Pressure (IOP) at Week 1 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint) | 08:00, 10:00 and 16:00 at week 1 |
| Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) | Intraocular Pressure (IOP) at Week 6 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint) | 08:00, 10:00 and 16:00 at week 6 |
| Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) | Intraocular Pressure (IOP) at Month 3 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint) | 08:00, 10:00 and 16:00 at month 3 |
| Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint) | The third key secondary endpoint, mean diurnal IOP at Week 1, the hypothesis of superiority of DE-117 to timolol was tested. Analysis using MMRM on Observed Cases. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at week 1. | week 1 |
| Prescott |
| Arizona |
| 86301-6610 |
| United States |
| Global Research Management | Glendale | California | 91204 | United States |
| United Medical Research Inst | Inglewood | California | 90301 | United States |
| Eye Research Foundation | Newport Beach | California | 92663-3642 | United States |
| North Bay Eye Associates Inc. | Petaluma | California | 94954-2387 | United States |
| Sacramento Eye Consultants | Sacramento | California | 95815-4605 | United States |
| AdvanceMed Clinical Research | San Diego | California | 92122 | United States |
| Michael K. Tran, MD, Inc. | Westminster | California | 92683-7071 | United States |
| Haas Vision Center | Colorado Springs | Colorado | 80919-5913 | United States |
| Florida Ophthalmic Institute | Gainesville | Florida | 32605-3192 | United States |
| St. Michaels Eye Laser Institute | Largo | Florida | 33770-3225 | United States |
| International Eye Associates PA | Ormond Beach | Florida | 32174 | United States |
| East Florida Eye Institute | Stuart | Florida | 34994 | United States |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | United States |
| Seidenberg Protzko Eye Associates | Havre de Grace | Maryland | 21078 | United States |
| Great Lakes Eye Care P.C | Saint Joseph | Michigan | 49085 | United States |
| Discover Vision Centers | Independence | Missouri | 64055-6974 | United States |
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | United States |
| Comprehensive Eye Care Ltd. | Washington | Missouri | 63090-3010 | United States |
| AdvanceMed Clinical Research | Las Vegas | Nevada | 89123 | United States |
| Rochester Ophthalmological Group, PC | Rochester | New York | 14618 | United States |
| Asheville Eye Associates | Asheville | North Carolina | 28803-2493 | United States |
| Abrams Eye Center | Cleveland | Ohio | 44115 | United States |
| Total Eye Care PA | Memphis | Tennessee | 38119-5770 | United States |
| VRF Eye Specialty Group | Memphis | Tennessee | 38120 | United States |
| Glaucoma Associates of Texas | Dallas | Texas | 75231-2168 | United States |
| Houston Eye Associates HEA - Gramercy Location | Houston | Texas | 77025-1756 | United States |
| Baylor College of Medicine Alkek Eye Center | Houston | Texas | 77030 | United States |
| The Eye Clinic of Texas | League City | Texas | 77573-5148 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240-1502 | United States |
| Stacy R. Smith M.D. P.C. | Salt Lake City | Utah | 84117 | United States |
| Vistar Eye Center | Roanoke | Virginia | 24016-5100 | United States |
| Tidewater Clinical Research | Virginia Beach | Virginia | 23456 | United States |
Timolol Maleate Ophthalmic Solution 0.5% Twice a day (20:00 & 08:00)
| Safety and Full Analysis Set (FAS) Participants |
|
| COMPLETED |
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| NOT COMPLETED |
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The Baseline Participants are similar in count to the Safety and Full Analysis Set (FAS) Participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) | DE-117 0.002% QD in the evening (20:00) and vehicle QD in the morning (08:00). |
| BG001 | Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) | Timolol Maleate Ophthalmic Solution 0.5% Twice a day (20:00 & 08:00) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 (IOP) at Week 1 | Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 1. | Posted | Least Squares Mean | Standard Error | mmHg | 08:00, 10:00 and 16:00 at Week 1 |
|
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| ||||||||||||||||||||||||||||
| Primary | Intraocular Pressure (IOP) at Week 6 | Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 6. | Posted | Least Squares Mean | Standard Error | mmHg | 08:00, 10:00 and 16:00 at Week 6 |
|
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| Primary | Intraocular Pressure (IOP) at Month 3 | Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Month 3. | Posted | Least Squares Mean | Standard Error | mmHg | 08:00, 10:00 and 16:00 at Month 3 |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint) | To determine if the mean diurnal IOP reduction with DE-117 ophthalmic solution 0.002% is superior to that of Timolol Maleate ophthalmic solution 0.5% at Month 3 in subjects with OAG or OHT. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at Month 3. | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Month 3. | Posted | Least Squares Mean | Standard Error | mmHg | Month 3 |
|
| |||||||||||||||||||||||||||||
| Secondary | Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) | Intraocular Pressure (IOP) at Week 1 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint) | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 1. | Posted | Least Squares Mean | Standard Error | mmHg | 08:00, 10:00 and 16:00 at week 1 |
|
| |||||||||||||||||||||||||||||
| Secondary | Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) | Intraocular Pressure (IOP) at Week 6 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint) | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 6. | Posted | Least Squares Mean | Standard Error | mmHg | 08:00, 10:00 and 16:00 at week 6 |
|
| |||||||||||||||||||||||||||||
| Secondary | Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) | Intraocular Pressure (IOP) at Month 3 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint) | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Month 3. | Posted | Least Squares Mean | Standard Error | mmHg | 08:00, 10:00 and 16:00 at month 3 |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint) | The third key secondary endpoint, mean diurnal IOP at Week 1, the hypothesis of superiority of DE-117 to timolol was tested. Analysis using MMRM on Observed Cases. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at week 1. | Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 1. | Posted | Least Squares Mean | Standard Error | mmHg | week 1 |
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Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.
The safety population includes all randomized participants who received at least one dose of the study medication and similar in count to the Full Analysis Set population.
Other Adverse events data is a summary of AEs observed at a rate of 1.0% or higher by System Organ Class and Preferred Term. Threshold of 0.98% is considered 1% and therefore added.
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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 | DE-117 Ophthalmic Solution | Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months | 1 | 204 | 7 | 204 | 68 | 204 |
| EG001 | Timolol Maleate Ophthalmic Solution 0.5% | Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months | 0 | 205 | 1 | 205 | 49 | 205 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoid macular oedema | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
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| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
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| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Anterior chamber cell | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cystoid macular oedema | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Erythema of eyelid | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Growth of eyelashes | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Instillation site pain | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA (21.1) | Systematic Assessment |
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| Vital dye staining cornea present | Investigations | MedDRA (21.1) | Systematic Assessment |
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| Vitreous detachment | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | MedDRA (21.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (21.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | 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, 2019 | Jun 26, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| >=65 years |
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| Male |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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| Multiple |
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| 10:00 |
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| 16:00 |
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