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This study is designed to see how safe and effective a new eye drop, called Reformulated PG324, is for lowering eye pressure in people with open-angle glaucoma (OAG) or ocular hypertension (OHT).
About 470 adults with OAG or OHT will be randomly divided into 2 groups. One group will use the new Reformulated PG324 eye drops, and the other group will use the marketed PG324 eye drops. This study will be double-masked, so neither the researcher nor the participant will know which eye drop was administered. The expected individual duration of participation is approximately 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reformulated PG324 | Experimental | One drop of netarsudil 0.01%/latanoprost 0.005% ophthalmic solution in each eye in the evening for three months |
|
| PG324 | Active Comparator | One drop of netarsudil 0.02%/latanoprost 0.005% ophthalmic solution in each eye in the evening for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution | Drug | Investigational ophthalmic solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure at each timepoint post-randomization | Intraocular pressure (IOP) will be measured with a Goldmann tonometer and recorded in millimeters mercury (mmHg). IOP will be calculated as the mean of two readings or the median of three readings at each timepoint. | Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with moderate to severe conjunctival hyperemia as assessed by biomicroscopy | The subject will undergo a slit lamp examination at all visits, except for dispensing visits. The presence of moderate to severe conjunctival hyperemia (redness) will be recorded. | Up to Month 3/study exit |
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Key Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Trinity Research Group | Dothan | Alabama | 36301 | United States | ||
| Eye Doctors of Arizona |
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| Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution | Drug | Commercially available ophthalmic solution |
|
|
| Proportion of subjects with conjunctival hyperemia adverse events |
Occurrences of conjunctival hyperemia (redness) adverse events, either subject or investigator reported, will be recorded at each visit. |
| Up to Month 3/study exit |
| Mean change from diurnally adjusted baseline IOP at each timepoint post-randomization | Intraocular pressure (IOP) will be measured with a Goldmann tonometer and recorded in millimeters mercury (mmHg). IOP will be calculated as the mean of two readings or the median of three readings at each timepoint. Change is defined as the follow-up (Week 2, Week 6, and Month 3) minus baseline (Day 1) at each timepoint. | Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours |
| Percent change from diurnally adjusted baseline IOP at each timepoint post-randomization | Intraocular pressure (IOP) will be measured with a Goldmann tonometer and recorded in millimeters mercury (mmHg). IOP will be calculated as the mean of two readings or the median of three readings at each timepoint. Change is defined as the follow-up (Week 2, Week 6, and Month 3) minus baseline (Day 1) at each timepoint. | Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours |
| Mean TSS-IOP scores at Month 3 | The Treatment Satisfaction Survey for Intraocular Pressure (TSS-IOP) module is a 15-item questionnaire designed to assess subject satisfaction with ocular hypotensive medication(s). Subjects will respond to each item using a 5-, 6-, or 7-point Likert Scale. Individual scores will be computed by adding the scale values of items within a satisfaction category and transforming the resulting value into a score between 0 and 100. Higher scores are indicative of greater satisfaction. The questionnaire will be self-administered. | Month 3 |
| Mean Changes in TSS-IOP scores from Screening to Month 3 | The Treatment Satisfaction Survey for Intraocular Pressure (TSS-IOP) module is a 15-item questionnaire designed to assess subject satisfaction with ocular hypotensive medication(s). Subjects will respond to each item using a 5-, 6-, or 7-point Likert Scale. Individual scores will be computed by adding the scale values of items within a satisfaction category and transforming the resulting value into a score between 0 and 100. Higher scores are indicative of greater satisfaction. The questionnaire will be self-administered. | Month 3 |
| Phoenix |
| Arizona |
| 85028 |
| United States |
| Orange County Ophthalmology Medical Group | Garden Grove | California | 92843 | United States |
| United Medical Research Institute | Inglewood | California | 90301 | United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| North Bay Eye Associates | Petaluma | California | 94954 | United States |
| Sacramento Eye Consultants | Sacramento | California | 95815 | United States |
| Central Florida Eye Specialists | DeLand | Florida | 32720 | United States |
| Glaucoma Specialists of South Florida | Delray Beach | Florida | 33484 | United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32256 | United States |
| Central Florida Eye Associates | Lakeland | Florida | 33805 | United States |
| The Eye Institute of West Florida | Largo | Florida | 33770 | United States |
| Lee Shettle Eye | Largo | Florida | 33773 | United States |
| North Georgia Eye Associates | Gainesville | Georgia | 30501 | United States |
| Coastal Research Associates | Roswell | Georgia | 30076 | United States |
| Kannarr Eye Care LLC | Pittsburg | Kansas | 66762 | United States |
| NorthEast Eye Research Associates, LLC | Westborough | Massachusetts | 01581 | United States |
| Coldwater Vision Research | Coldwater | Mississippi | 38618 | United States |
| Las Vegas Eye Institute | Henderson | Nevada | 89052 | United States |
| Rochester Ophthalmological Group | Rochester | New York | 14618 | United States |
| Albemarle Eye Center | Elizabeth City | North Carolina | 27909 | United States |
| Oculus Research, Inc. | Garner | North Carolina | 27529 | United States |
| CORE, Inc. | Shelby | North Carolina | 28150 | United States |
| Midwest Eye Center | Cincinnati | Ohio | 45236 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Southern College of Optometry | Memphis | Tennessee | 38104 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | United States |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000603944 | netarsudil |
| D000077338 | Latanoprost |
| D009883 | Ophthalmic Solutions |
| 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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