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To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo
Trabecular outflow facility is a measure of aqueous humor dynamics; effect of netarsudil on this parameter as well as on intraocular pressure and episcleral venous pressure was evaluated in this study. Netarsudil treatment was given in one eye and placebo given in contralateral eye for 7 consecutive days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Netarsudil Ophthalmic Solution 0.02% | Experimental | Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye |
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| Placebo Comparator | Placebo Comparator | Placebo comparator administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netarsudil Ophthalmic Solution 0.02% | Drug | 1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility | Mean diurnal change from baseline in trabecular (tonographic) outflow facility. | Study treatment was administered for 7 days, and outcome measures collected on Day 8 |
| Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility. | Mean diurnal change from baseline in trabecular (tonographic) outflow facility. | Study treatment was administered for 7 days, and outcome measures collected on Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP) | Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants) | Study treatment was administered for 7 days, and outcome measures collected on Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
Ophthalmic:
Clinically significant ocular disease
Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
Intraocular pressure ≥30 mmHg in either eye
A difference in IOP between eyes >4mmHg at qualification visit
Use of more than two ocular hypotensive medications within 30 days of screening
Known hypersensitivity to any component of the formulation
Previous glaucoma surgery or refractive surgery
Keratorefractive surgery in either eye
Report of ocular injury in either eye within the six months prior to screening or ocular or non-refractive surgery within 3 months prior to screening
Recent or current ocular infection or inflammation in either eye
Use of ocular medication in either eye of any kind within 30 days of screening
Mean central corneal thickness greater than 620 μm in either eye
Any abnormality preventing reliable applanation tonometry of either eye
Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP) measurement (applicable to 1 site only)
Systemic:
Clinically significant abnormalities within 6 weeks prior to screening
Clinically significant systemic disease
Participation in any investigational study within 60 days prior to screening
Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Ramirez-Davis | Aerie Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Duke Eye Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Randomized Patients | 1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye |
| 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 | Aug 16, 2017 | Apr 18, 2019 |
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Paired comparison study
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| Placebo Comparator | Other | 1 drop daily (QD), in the morning (AM) of Placebo comparator administered to one eye and Netarsudil Ophthalmic Solution 0.02% to the contralateral eye |
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| Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP) | Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants) | Study treatment was administered for 7 days, and outcome measures collected on Day 8 |
| Durham |
| North Carolina |
| 27710 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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Modified intent-to-treat (mITT) population
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Patients | 1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and placebo comparator to the contralateral eye |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility | Mean diurnal change from baseline in trabecular (tonographic) outflow facility. | Modified intent-to-treat (mITT) population | Posted | Mean | Standard Deviation | mcl/min/mmHg | Study treatment was administered for 7 days, and outcome measures collected on Day 8 |
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| Primary | Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility. | Mean diurnal change from baseline in trabecular (tonographic) outflow facility. | Modified intent-to-treat (mITT) population | Posted | Mean | Standard Deviation | percentage change | Study treatment was administered for 7 days, and outcome measures collected on Day 8 |
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| Secondary | Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP) | Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants) | Modified intent-to-treat (mITT) population, EVP analyzed in 9 participants | Posted | Mean | Standard Deviation | mmHg | Study treatment was administered for 7 days, and outcome measures collected on Day 8 |
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| Secondary | Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP) | Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants) | Modified intent-to-treat (mITT) population, EVP analyzed in 9 participants | Posted | Mean | Standard Deviation | percentage change | Study treatment was administered for 7 days, and outcome measures collected on Day 8 |
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7 Days
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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 | Netarsudil Ophthalmic Solution 0.02% | Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye | 0 | 20 | 0 | 20 | 13 | 20 |
| EG001 | Placebo Comparator | Placebo comparator was administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye | 0 | 20 | 0 | 20 | 0 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Eye Swelling | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theresa GH Heah, MD, MBA | Aerie Pharmaceuticals, Inc | 908-947-3844 | theah@aeriepharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2018 | Apr 18, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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