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

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ClinicalTrials.gov Identifier: NCT03310580
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:
To test the safety and effectiveness of netarsudil 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with elevated intraocular pressure

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma or Ocular Hypertension Drug: Netarsudil Ophthalmic Solution 0.02% Drug: Netarsudil Ophthalmic Solution 0.04% Drug: Netarsudil 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: Netarsudil Ophthalmic Solution 0.02%
Netarsudil ophthalmic solution 0.02%; 1 drop daily to each eye for 28 days
Drug: Netarsudil Ophthalmic Solution 0.02%
Topical sterile ophthalmic solution

Experimental: Netarsudil Ophthalmic Solution 0.04%
Netarsudil ophthalmic solution 0.02%; 1 drop daily to each eye for 28 days
Drug: Netarsudil Ophthalmic Solution 0.04%
Topical sterile ophthalmic solution

Placebo Comparator: Placebo Comparator
Netarsudil ophthalmic solution placebo; 1 drop daily to each eye for 28 days
Drug: Netarsudil Ophthalmic Solution Placebo
Topical sterile ophthalmic solution




Primary Outcome Measures :
  1. Mean diurnal IOP within a treatment by Goldman Applanation [ Time Frame: 29 days ]

Secondary Outcome Measures :
  1. Mean diurnal IOP at Days 8 and 15 [ Time Frame: Days 8 and 15 ]
  2. Mean change from baseline in mean diurnal IOP at each post-treatment visit [ Time Frame: Days 8, 15, 29 ]
  3. Mean percent change from baseline in mean diurnal IOP at each post-treatment visit [ Time Frame: Days 8, 15, 29 ]
  4. Mean IOP at each post-treatment time point [ Time Frame: Days 8, 15, 29 ]
  5. Mean change from diurnally adjusted baseline IOP at each post-treatment time point [ Time Frame: Days 8, 15, 29 ]
  6. Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint [ Time Frame: Days 8, 15, 29 ]
  7. Percentages of subjects achieving pre-specified mean, mean change, and percent mean change in mean diurnal IOP levels [ Time Frame: Day 29 ]


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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 study duration
  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


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Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
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Study Director: Nancy Ramirez-Davis Aerie Pharmaceuticals

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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
Last Update Posted: December 21, 2018
Last Verified: October 2018

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