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To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PG324 Ophthalmic Solution 0.01% | Experimental | Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution |
|
| PG324 Ophthalmic Solution 0.02% | Experimental | Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution |
|
| Netarsudil (AR-13324) Ophthalmic Solution 0.02% | Active Comparator | Netarsudil 0.02% ophthalmic solution |
|
| Latanoprost Ophthalmic Solution 0.005% | Active Comparator | Latanoprost 0.005% ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG324 Ophthalmic Solution 0.01% | Drug | 1 drop in the evening (PM), once daily (QD), both eyes (OU) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29. | Study treatment was administered for 28 days, and outcome measures collected on Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
Ophthalmic:
Systemic:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Ramirez, M.S. | Aerie Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenneth Sall, M.D. | Artesia | California | 90701 | United States | ||
| United Medical Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26209587 | Derived | Lewis RA, Levy B, Ramirez N, Kopczynski CC, Usner DW, Novack GD; PG324-CS201 Study Group. Fixed-dose combination of AR-13324 and latanoprost: a double-masked, 28-day, randomised, controlled study in patients with open-angle glaucoma or ocular hypertension. Br J Ophthalmol. 2016 Mar;100(3):339-44. doi: 10.1136/bjophthalmol-2015-306778. Epub 2015 Jul 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PG324 Ophthalmic Solution 0.01% | PG324 Ophthalmic Solution 0.01% 1 drop in the evening (PM), once daily (QD), both eyes (OU) |
| FG001 | PG324 Ophthalmic Solution 0.02% | PG324 Ophthalmic Solution 0.02% 1 drop in the evening (PM), once daily (QD), both eyes (OU) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PG324 Ophthalmic Solution 0.02% | Drug | 1 drop in the evening (PM), once daily (QD), both eyes (OU) |
|
| Netarsudil (AR-13324) Ophthalmic Solution 0.02% | Drug | 1 drop in the evening (PM), once daily (QD), both eyes (OU) |
|
| Latanoprost Ophthalmic Solution 0.005% | Drug | 1 drop in the evening (PM), once daily (QD), both eyes (OU) |
|
| Inglewood |
| California |
| 90301 |
| United States |
| Aesthetic Eye Care Institute | Newport Beach | California | 92657 | United States |
| Bacharach practice | Petaluma | California | 94954 | United States |
| Centre For Health Care | Poway | California | 92064 | United States |
| Clayton Eye Center | Morrow | Georgia | 30260 | United States |
| Coastal Research Associates, LLC | Roswell | Georgia | 30076 | United States |
| Bradley Kwapiszeski, MD | Shawnee Mission | Kansas | 66204 | United States |
| Taustine Eye Center | Louisville | Kentucky | 40217 | United States |
| Seidenberg Protzko Eye Associates | Havre de Grace | Maryland | 21078 | United States |
| Great Lakes Eye Care | Saint Joseph | Michigan | 49085 | United States |
| Comprehensive Eye Care | St Louis | Missouri | 63090 | United States |
| Ophthalmic Consultants of Long Island | Lynbrook | New York | 11563 | United States |
| Rochester Ophthalmological Group | Rochester | New York | 14618 | United States |
| Charlotte Eye Ear Nose & Throat Associates, P.A. | Belmont | North Carolina | 28012 | United States |
| Michael E. Tepedino, M.D. | High Point | North Carolina | 27262 | United States |
| The Eye Institute | Tulsa | Oklahoma | 74104 | United States |
| Texan Eye | Austin | Texas | 78731 | United States |
| Glaucoma Associates of Texas - Dallas Office | Dallas | Texas | 75231 | United States |
| Cataract & Glaucoma Center | El Paso | Texas | 79902 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Stacy R. Smith, M.D. | Salt Lake City | Utah | 84117 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| FG002 | Netarsudil (AR-13324) Ophthalmic Solution 0.02% | Netarsudil (AR-13324) Ophthalmic Solution 0.02% 1 drop in the evening (PM), once daily (QD), both eyes (OU) |
| FG003 | Latanoprost Ophthalmic Solution 0.005% | Latanoprost Ophthalmic Solution 0.005% 1 drop in the evening (PM), once daily (QD), both eyes (OU) |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PG324 Ophthalmic Solution 0.01% | PG324 Ophthalmic Solution 0.01% 1 drop in the evening (PM), once daily (QD), both eyes (OU) |
| BG001 | PG324 Ophthalmic Solution 0.02% | PG324 Ophthalmic Solution 0.02% 1 drop in the evening (PM), once daily (QD), both eyes (OU) |
| BG002 | Netarsudil (AR-13324) Ophthalmic Solution 0.02% | Netarsudil (AR-13324) Ophthalmic Solution 0.02% 1 drop in the evening (PM), once daily (QD), both eyes (OU) |
| BG003 | Latanoprost Ophthalmic Solution 0.005% | Latanoprost Ophthalmic Solution 0.005% 1 drop daily in the evening (PM), once daily (QD), both eyes (OU) |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| 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) | The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29. | Modified intent to treat (mITT) population | Posted | Mean | Standard Deviation | mmHg | Study treatment was administered for 28 days, and outcome measures collected on Day 29 |
|
|
|
|
Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
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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 | PG324 Ophthalmic Solution 0.01% | PG324 Ophthalmic Solution 0.01% 1 drop in the evening (PM), once daily (QD), both eyes (OU) | 0 | 74 | 0 | 74 | 46 | 73 |
| EG001 | PG324 Ophthalmic Solution 0.02% | PG324 Ophthalmic Solution 0.02% 1 drop in the evening (PM), once daily (QD), both eyes (OU) | 0 | 73 | 0 | 73 | 55 | 73 |
| EG002 | Netarsudil (AR-13324) Ophthalmic Solution | Netarsudil (AR-13324) Ophthalmic Solution 1 drop in the evening (PM), once daily (QD), both eyes (OU) | 0 | 78 | 0 | 78 | 49 | 78 |
| EG003 | Latanoprost Ophthalmic Solution | Latanoprost Ophthalmic Solution Latanoprost Ophthalmic Solution: 1 drop daily (evening) | 0 | 73 | 3 | 73 | 12 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcerative Keratitis | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Instillation Site Erythema | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Instillation Site Pain | General disorders | MedDRA (15.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theresa GH Heah, MD, MBA | Aerie Pharmaceuticals, Inc | 908-947-3844 | theah@aeriepharma.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000603944 | netarsudil |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| 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 |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Day 29, Diurnal Mean |
|
PG324 0.02% vs. netarsudil |
| Superiority |
| t-test, 2 sided | PG324 0.01% vs. latanoprost | <0.0001 | Superiority |
| t-test, 2 sided | PG324 0.02% vs. latanoprost | <0.0001 | Superiority |