Safety and Efficacy Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension Phase II: Primary Open Angle Glaucoma or Ocular Hypertension

Overview

ConditionPrimary Open Angle Glaucoma or Ocular Hypertension
TreatmentsNetarsudil Ophthalmic Solution 0.02%, Netarsudil Ophthalmic Solution 0.04%, Netarsudil Ophthalmic Solution Placebo
PhasePhase 2
SponsorAerie Pharmaceuticals
Start DateNovember 2017
End DateOctober 2018
Trial Size180
Trial IdentifierNCT03310580

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

Study Design

AllocationRandomized
Intervention ModelParallel Assignment
Primary PurposeTreatment
MaskingTriple (Participant, Care Provider, Investigator)

Study Arms

  • Experimental: Netarsudil Ophthalmic Solution 0.02%
    • Netarsudil ophthalmic solution 0.02%; 1 drop daily to each eye for 28 days
    • Intervention: Drug: Netarsudil Ophthalmic Solution 0.02%
  • Experimental: Netarsudil Ophthalmic Solution 0.04%
    • Netarsudil ophthalmic solution 0.02%; 1 drop daily to each eye for 28 days
    • Intervention: Drug: Netarsudil Ophthalmic Solution 0.04%
  • Placebo Comparator: Placebo Comparator
    • Netarsudil ophthalmic solution placebo; 1 drop daily to each eye for 28 days
    • Intervention: Drug: Netarsudil Ophthalmic Solution Placebo

Eligibility Critera

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

Additional Information

Official TitleA 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

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