Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
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ClinicalTrials.gov Identifier: NCT03233308 |
Recruitment Status :
Completed
First Posted : July 28, 2017
Results First Posted : June 11, 2019
Last Update Posted : August 6, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Open Angle Glaucoma or Ocular Hypertension | Drug: Netarsudil Ophthalmic Solution 0.02% Other: Placebo Comparator | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Paired comparison study |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Double-Masked, Randomized, Placebo-Controlled Study of Trabecular Outflow Facility Following Treatment With Netarsudil Ophthalmic Solution 0.02% (AR-13324) in Subjects With Elevated Intraocular Pressure |
Actual Study Start Date : | October 20, 2017 |
Actual Primary Completion Date : | April 19, 2018 |
Actual Study Completion Date : | April 19, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Netarsudil Ophthalmic Solution 0.02%
Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye
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Drug: Netarsudil Ophthalmic Solution 0.02%
1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye Other: Placebo Comparator 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 |
Placebo Comparator: Placebo Comparator
Placebo comparator administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye
|
Drug: Netarsudil Ophthalmic Solution 0.02%
1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye Other: Placebo Comparator 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 |
- Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility [ Time Frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8 ]Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
- Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility. [ Time Frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8 ]Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
- Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP) [ Time Frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8 ]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)
- Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP) [ Time Frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8 ]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)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must be 18 years of age or older
- Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both eyes
- Unmedicated intraocular pressure (IOP) >20 mmHg and < 30 mmHg in both eyes at first qualification visit
- Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
- Able to give informed consent and follow study instructions
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233308
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, North Carolina | |
Duke Eye Center | |
Durham, North Carolina, United States, 27710 |
Study Director: | Nancy Ramirez-Davis | Aerie Pharmaceuticals |
Documents provided by Aerie Pharmaceuticals:
Responsible Party: | Aerie Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03233308 History of Changes |
Other Study ID Numbers: |
AR-13324-CS206 |
First Posted: | July 28, 2017 Key Record Dates |
Results First Posted: | June 11, 2019 |
Last Update Posted: | August 6, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Aqueous Humor Dynamics Trabecular Outflow Netarsudil |
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Hypertension Vascular Diseases |
Cardiovascular Diseases Eye Diseases Ophthalmic Solutions Pharmaceutical Solutions |