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The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
During Stage 1, approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms: 3 different concentrations of AR-17043, placebo comparator, or netarsudil 0.02% (Rhopressa®) for a treatment duration of 7 days.
During Stage 2, approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms: low and high concentrations of PG043 (AR-17043/latanoprost 0.005%), AR-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (Rocklatan®) for a treatment duration of 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR-17043 low concentration (Stage 1) | Experimental | AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. |
|
| AR-17043 medium concentration (Stage 1) | Experimental | AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. |
|
| AR-17043 high concentration (Stage 1) | Experimental | AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. |
|
| AR-17043 vehicle (Stage 1) | Placebo Comparator | AR-17043 Vehicle, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. |
|
| Rhopressa (Stage 1) | Active Comparator | Netarsudil 0.02% Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR-17043 Ophthalmic Solution | Drug | Investigational monotherapy supplied in three concentration levels: low, medium, high |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean diurnal IOP at Day 8 (Stage 1) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the four measurements. | Day 8 (8:00, 10:00, 12:00, 16:00) |
| Mean diurnal IOP at Day 29 (Stage 2) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the three measurements. | Day 29 (8:00, 10:00, 16:00) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP at each post-treatment timepoint (Stage 1) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint. | Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) |
| Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1) |
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Stage 1 Key Inclusion Criteria;
Stage 2 Key Inclusion Criteria:
Stage 1 and Stage 2 Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Pharma | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Ophthalmology Medical Group | Garden Grove | California | 92843 | United States | ||
| United Medical Research Institute |
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|
| PG043 low concentration (Stage 2) | Experimental | PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. |
|
| PG043 high concentration (Stage 2) | Experimental | PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. |
|
| AR-17043 high concentration (Stage 2) | Active Comparator | AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. |
|
| Latanoprost (Stage 2) | Active Comparator | Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. |
|
| Rocklatan (Stage 2) | Active Comparator | Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. |
|
| PG043 Ophthalmic Solution | Drug | Investigational fixed dose combination supplied in two concentration levels: low and high |
|
| Latanoprost 0.005% Ophthalmic Solution | Drug | Marketed monotherapy |
|
|
| Netarsudil 0.02% Ophthalmic Solution | Drug | Marketed monotherapy |
|
|
| Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution | Drug | Marketed fixed dose combination |
|
|
| AR-17043 Vehicle | Drug | Placebo comparator |
|
Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment. |
| Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) |
| Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment. | Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) |
| Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment. | Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) |
| Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment. | Baseline (8:00, 10:00, 12:00, 16:00); Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) |
| Mean IOP at each post-treatment timepoint (Stage 2) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint. | Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) |
| Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment. | Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) |
| Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment. | Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) |
| Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment. | Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) |
| Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2) | Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment. | Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) |
| Inglewood |
| California |
| 90301 |
| United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| North Bay Eye Associates | Petaluma | California | 94954 | United States |
| Eye Center of Northern Colorado, PC | Fort Collins | Colorado | 80528 | United States |
| Coastal Research Associates | Roswell | Georgia | 30076 | United States |
| Rochester Ophthalmological Group | Rochester | New York | 14618 | United States |
| James D. Branch Ophthalmology | Winston-Salem | North Carolina | 27101 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| University Eye Specialists | Maryville | Tennessee | 37803 | United States |
| Total Eye Care PA | Memphis | Tennessee | 38119 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | United States |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| D009883 | Ophthalmic Solutions |
| C000603944 | netarsudil |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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