Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal Intraocular Pressure.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Netarsudil Ophthalmic Solution 0.02% | Experimental | 1 drop in each eye (OU) daily |
|
| Netarsudil Ophthalmic Solution Vehicle | Placebo Comparator | 1 drop in each eye (OU) daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netarsudil ophthalmic solution 0.02% | Drug | Once daily in both eyes (OU) in the evening (PM) for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure (IOP) Over Nocturnal Time Period | The primary efficacy endpoint was the mean change from baseline in mean nocturnal IOP (defined as the mean of the 4 nocturnal time points: 21:00, 00:00, 03:00, and 06:00 hours) on Day 8/Day 9 | Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 7 days (day 1/2 to day 8/9) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Theresa Heah, MD | Aerie Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nancy Ramirez | Bedminster | New Jersey | 07921 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33244711 | Derived | Peace JH, McKee HJ, Kopczynski CC. A Randomized, Phase 2 Study of 24-h Efficacy and Tolerability of Netarsudil in Ocular Hypertension and Open-Angle Glaucoma. Ophthalmol Ther. 2021 Mar;10(1):89-100. doi: 10.1007/s40123-020-00322-1. Epub 2020 Nov 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects who agreed to participate in this study were assessed during a screening visit and those who were already using ocular hypotensive medication had to undergo a washout for a specified period (5 days to 4 weeks, depending on the medication) prior to the Qualification visit.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Netarsudil Ophthalmic Solution 0.02% | 1 drop in each eye (OU) daily in the evening (PM) |
| FG001 | Netarsudil Ophthalmic Solution Vehicle | 1 drop in each eye (OU) daily in the evening (PM) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ITT
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Netarsudil Ophthalmic Solution 0.02% | 1 drop in each eye daily (OU) in the evening (PM) |
| BG001 | Netarsudil Ophthalmic Solution Vehicle | 1 drop in each eye daily (OU) in the evening |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Intraocular Pressure (IOP) Over Nocturnal Time Period | The primary efficacy endpoint was the mean change from baseline in mean nocturnal IOP (defined as the mean of the 4 nocturnal time points: 21:00, 00:00, 03:00, and 06:00 hours) on Day 8/Day 9 | ITT | Posted | Mean | Standard Deviation | mmHg | Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9 |
|
Adverse event data was collected over 7 days from day 1/2 to day 8/9.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Netarsudil Ophthalmic Solution 0.02% | 1 drop in each eye (OU) daily in the evening (PM) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Ramirez-Davis, Director of Clinical Project Management | Aerie Pharmaceuticals, Inc. | 908-947-3543 | nramirez@aeriepharma.com |
Not provided
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
Not provided
Not provided
| ID | Term |
|---|---|
| C000603944 | netarsudil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Netarsudil Ophthalmic Solution Vehicle | Other | Once daily in both eyes (OU) in the evening (PM) for 7 days |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | ITT | Posted | Count of Participants | Participants | 7 days (day 1/2 to day 8/9) |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Netarsudil Ophthalmic Solution Vehicle | 1 drop in each eye (OU) daily in the evening (PM) | 0 | 4 | 0 | 4 | 0 | 4 |
Not provided
Not provided