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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Arm: DE-117 QD | Experimental | DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD |
|
| Test Arm: DE-117 BID | Experimental | DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-117 Ophthalmic Solution QD | Drug | DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye |
|
| 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 |
| 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 |
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Inclusion Criteria:
Provide signed written informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East West Eye Institute | Los Angeles | California | 90013 | United States | ||
| Danbury Eye Specialist |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Arm: DE-117 BID | DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00) DE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye |
| FG001 | Drug Arm: DE-117 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 | Nov 13, 2018 | Jun 3, 2020 |
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| DE-117 Ophthalmic Solution BID | Drug | DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye |
|
| Danbury |
| Connecticut |
| 06810 |
| United States |
| Hernando Eye Institute | Brooksville | Florida | 34613 | United States |
| Levenson Eye Associates | Jacksonville | Florida | 32204 | United States |
| Seidenberg Protzko Eye Associates | Havre de Grace | Maryland | 21078 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63128 | United States |
| Eye Associates/SurgiCenter of Vineland | Vineland | New Jersey | 08361 | United States |
| Ophthalmic Consultants of Long Island | Lynbrook | New York | 11563 | United States |
| Apex Eye Clinical Research, LLC | Cincinnati | Ohio | 45242 | United States |
| Abrams Eye Center | Cleveland | Ohio | 44115 | United States |
| Scott & Christie and Associates PC | Cranberry Township | Pennsylvania | 16066 | United States |
| University Eye Specialist | Maryville | Tennessee | 37803 | United States |
| Advanced Vision Research | Nashville | Tennessee | 37205 | United States |
DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD
DE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Arm: DE-117 BID | DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00) DE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye |
| BG001 | Drug Arm: DE-117 QD | DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD DE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 (IOP) at Week 2 | Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg). | Posted | Least Squares Mean | Standard Error | mmHg | 08:00 at week 2 |
|
|
| |||||||||||||||||||||||||||||
| Primary | Intraocular Pressure (IOP) at Week 2 | Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg). | Posted | Least Squares Mean | Standard Error | mmHg | 12:00 at week 2 |
|
| ||||||||||||||||||||||||||||||
| Primary | Intraocular Pressure (IOP) at Week 2 | Intraocular pressure (IOP), the fluid pressure inside the eye, was mea... | Posted | Least Squares Mean | Standard Error | mmHg | 16:00 at week 2 |
|
| ||||||||||||||||||||||||||||||
| Primary | Intraocular Pressure (IOP) at Week 6 | Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg). | Posted | Least Squares Mean | Standard Error | mmHg | 08:00 at week 6 |
|
| ||||||||||||||||||||||||||||||
| Primary | Intraocular Pressure (IOP) at Week 6 | Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg). | Posted | Least Squares Mean | Standard Error | mmHg | 12:00 at week 6 |
|
| ||||||||||||||||||||||||||||||
| Primary | Intraocular Pressure (IOP) at Week 6 | Intraocular pressure (IOP), the fluid pressure inside the eye, was mea... | Posted | Least Squares Mean | Standard Error | mmHg | 16:00 at week 6 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Diurnal Intraocular Pressure (IOP) | Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg). | Posted | Least Squares Mean | Standard Error | mmHg | 6 weeks |
|
|
All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.
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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 | Test Arm: DE-117 BID | DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00) DE-117 Ophthalmic Solution BID: DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye | 0 | 48 | 0 | 48 | 20 | 48 |
| EG001 | Drug Arm: DE-117 QD | DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD DE-117 Ophthalmic Solution QD: DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye | 0 | 50 | 1 | 50 | 7 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Accommodation disorder | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Corneal pigmentation | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Glare | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vital dye staining cornea present | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 21.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
Site/Investigator is not permitted to publish results communications without Santen's consent until after a period of sixty (60 days) for Santen review/comment. Santen may request removal of any Confidential Information (other than Study results) from manuscripts or materials prior to submission or presentation. At Santen's request Site/Investigator has to withhold any publication if there is a patentable invention until such time as Santen is able to secure adequate patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R&D Quality Manager | Santen Inc | 415 268 9199 | evelyn.chikere@santen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2019 | Jun 3, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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