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Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension

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: NCT03310580
Recruitment Status : Completed
First Posted : October 16, 2017
Results First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:
To test the safety and effectiveness of AR-13324 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with open-angle glaucoma or ocular hypertension in US.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma or Ocular Hypertension Drug: AR-13324 Ophthalmic Solution 0.02% Drug: AR-13324 Ophthalmic Solution 0.04% Drug: AR-13324 Ophthalmic Solution Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety and Ocular Hypotensive Efficacy and Optimum Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension in the United States
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : October 25, 2018
Actual Study Completion Date : October 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Netarsudil

Arm Intervention/treatment
Experimental: AR-13324 Ophthalmic Solution 0.02%
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Drug: AR-13324 Ophthalmic Solution 0.02%
Administered to each eye, once daily (QD) in the evening (PM) for 28 days

Experimental: AR-13324 Ophthalmic Solution 0.04%
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Drug: AR-13324 Ophthalmic Solution 0.04%
Administered to each eye, once daily (QD) in the evening (PM) for 28 days

Placebo Comparator: Placebo Comparator
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Drug: AR-13324 Ophthalmic Solution Placebo
Administered to each eye, once daily (QD) in the evening (PM) for 28 days




Primary Outcome Measures :
  1. Mean Diurnal IOP (Intraocular Pressure) (mmHg) [ Time Frame: 28 Days ]
    Mean diurnal intraocular pressure (IOP) at week 4 (Day 29), measured by Goldman Applanation Tonometry (GAT).


Secondary Outcome Measures :
  1. Extent of Exposure [ Time Frame: 28 Days ]
    Exposure to study medication in days for all treatment groups



Information from the National Library of Medicine

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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 or older
  2. Be of Japanese ethnicity within the 2nd generation defined as (a) 1st generation born in Japan, immigrated to US and (b) 2nd generation - parents are 1st generation and patient was born in US as an American citizen
  3. Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
  4. Medicated intraocular pressure >/= 15 mmHg and < 30 mmHg in both eyes at screening
  5. OAG eyes - unmedicated IOP >/= 15 mmHg and < 35 mmHg at 2 qualification visits at 08:00, 10:00 and 16:00
  6. OHT eyes - unmedicated IOP >/= 22 mmHg and < 35mmHg at 08:00, 10:00 and 16:00
  7. Best corrected visual acuity + 1.0 logMAR or better by ETDRS in each eye
  8. Able to give signed informed consent and follow instructions

Exclusion Criteria:

  1. Clinically significant ocular disease
  2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma or narrow angles
  3. Intraocular pressure >/=35 mmHg in either eye
  4. Ocular hyperemia score of moderate (+2) at qualification visit #2
  5. Previous glaucoma intraocular surgery
  6. Refractive surgery in either eye
  7. Ocular injury within 6 months prior to screening or ocular surgery or non-refractive laser treatment within 3 months prior to screening
  8. Recent or current ocular infection or inflammation in either eye
  9. Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study
  10. Mean central corneal thickness > 620 µm in either eye
  11. Any abnormality preventing reliable applanation tonometry of either eye
  12. Known hypersensitivity to benzalkonium chloride or excipients of netarsudil ophthalmic solution
  13. Clinically significant abnormalities in screening lab tests
  14. Clinically significant systemic disease that might interfere with the study
  15. Participated in any investigational study within 30 days prior to screening
  16. Systemic medication that could have a substantial effect on IOP within 30 days prior to screening or anticipated during the study
  17. Women of child-bearing potential 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): NCT03310580


  Show 40 Study Locations
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] July 17, 2017
Statistical Analysis Plan  [PDF] August 30, 2018


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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03310580     History of Changes
Other Study ID Numbers: AR-13324-CS205
First Posted: October 16, 2017    Key Record Dates
Results First Posted: November 15, 2019
Last Update Posted: November 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions