Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03233308
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : June 18, 2018
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 Drug: Placebo Comparator Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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%; 1 drop daily, in the morning (QD AM), topical ocular; one eye for 7 days
Drug: Netarsudil Ophthalmic Solution
Topical sterile ophthalmic solution once daily

Placebo Comparator: Placebo Comparator
Netarsudil ophthalmic solution placebo; 1 drop in the morning (QD AM) on contralateral eye for 7 days
Drug: Placebo Comparator
Topical sterile ophthalmic solution once daily




Primary Outcome Measures :
  1. Mean change from baseline in the mean diurnal trabecular outflow facility [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Mean change from baseline in the mean intraocular pressure [ Time Frame: 7 days ]
  2. Mean change from baseline in the mean episcleral venous pressure [ Time Frame: 7 days ]
  3. All treatment-emergent AEs that occurs or worsens on or after the first treatment [ Time Frame: 7 days ]
  4. Observed and change from baseline in visual acuity [ Time Frame: 7 days ]
  5. Evaluation of anterior segment by slit-lamp biomicroscopy from baseline [ Time Frame: 7 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 angle glaucoma or ocular hypertension in both eyes
  3. Unmedicated intraocular pressure >20 mmHg and < 30 mmHg in both eyes at first qualification visit
  4. Corrected visual acuity equivalent to 20/200
  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. 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
  9. Recent or current ocular infection or inflammation in either eye
  10. Use of ocular medication in either eye of any kind within 30 days of screening
  11. Mean central corneal thickness greater than 620 μm in either eye
  12. Any abnormality preventing reliable applanation tonometry of either eye

    Systemic:

  13. Clinically significant abnormalities in any recent laboratory tests within 6 weeks prior to screening
  14. Clinically significant systemic disease
  15. Participation in any investigational study within 60 days prior to screening
  16. Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
  17. Women who are 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
Layout table for location information
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
Layout table for investigator information
Study Director: Nancy Ramirez-Davis Aerie Pharmaceuticals

Layout table for additonal information
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
Last Update Posted: June 18, 2018
Last Verified: July 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions