Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

• ClinicalTrials.gov Identifier: NCT03233308
• Recruitment Status: Completed
• First Posted: July 28, 2017
• Results First Posted: June 11, 2019
• Last Update Posted: August 6, 2019
• Sponsor: Aerie Pharmaceuticals
• Information provided by (Responsible Party): Aerie Pharmaceuticals

Study Description

Brief Summary:

To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo

Condition or disease	Intervention/treatment	Phase
Primary Open Angle Glaucoma or Ocular Hypertension	Drug: Netarsudil Ophthalmic Solution 0.02%; Other: Placebo Comparator	Phase 2

Detailed Description:

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.

Study Design

• 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

Arms and Interventions

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	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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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)
2. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Must be 18 years of age or older
2. Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both eyes
3. Unmedicated intraocular pressure (IOP) >20 mmHg and < 30 mmHg in both eyes at first qualification visit
4. Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
5. Able to give informed consent and follow study instructions

Exclusion Criteria:

Ophthalmic:

1. Clinically significant ocular disease
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
3. Intraocular pressure ≥30 mmHg in either eye
4. A difference in IOP between eyes >4mmHg at qualification visit
5. Use of more than two ocular hypotensive medications within 30 days of screening
6. Known hypersensitivity to any component of the formulation
7. Previous glaucoma surgery or refractive surgery
8. Keratorefractive surgery in either eye
9. 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
10. Recent or current ocular infection or inflammation in either eye
11. Use of ocular medication in either eye of any kind within 30 days of screening
12. Mean central corneal thickness greater than 620 μm in either eye
13. Any abnormality preventing reliable applanation tonometry of either eye

14. Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP) measurement (applicable to 1 site only)

    Systemic:

15. Clinically significant abnormalities within 6 weeks prior to screening
16. Clinically significant systemic disease
17. Participation in any investigational study within 60 days prior to screening
18. Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
19. Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, North Carolina

Duke Eye Center

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Aerie Pharmaceuticals

Investigators

• Study Director: Nancy Ramirez-Davis; Aerie Pharmaceuticals

  Study Documents (Full-Text)

Documents provided by Aerie Pharmaceuticals:

Study Protocol  [PDF] August 16, 2017

Statistical Analysis Plan  [PDF] February 5, 2018

More Information

• Responsible Party: Aerie Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03233308 History of Changes
• Other Study ID Numbers: AR-13324-CS206
• First Posted: July 28, 2017
• 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

Keywords provided by Aerie Pharmaceuticals:

Aqueous Humor Dynamics; Trabecular Outflow; Netarsudil

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Ophthalmic Solutions; Pharmaceutical Solutions