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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 : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Netarsudil

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




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)



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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

Information from the National Library of Medicine

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


Locations
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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
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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


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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: June 11, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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