Phase 2
Completed N=42
Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension
Primary Open Angle Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT03310580 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Mean Diurnal IOP (Intraocular Pressure) (mmHg) — 14.35; 14.33; 17.32 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Diurnal IOP (Intraocular Pressure) (mmHg) |
14.35; 14.33; 17.32 | — |
| SECONDARY Extent of Exposure |
27.9; 26.8; 27.4 | — |
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older
- 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
- Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
- Medicated intraocular pressure >/= 15 mmHg and /= 15 mmHg and /= 22 mmHg and /=35 mmHg in either eye
- Ocular hyperemia score of moderate (+2) at qualification visit #2
- Previous glaucoma intraocular surgery
- Refractive surgery in either eye
- Ocular injury within 6 months prior to screening or ocular surgery or non-refractive laser treatment within 3 months prior to screening
- Recent or current ocular infection or inflammation in either eye
- Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study
- Mean central corneal thickness > 620 µm in either eye
- Any abnormality preventing reliable applanation tonometry of either eye
- Known hypersensitivity to benzalkonium chloride or excipients of netarsudil ophthalmic solution
- Clinically significant abnormalities in screening lab tests
- Clinically significant systemic disease that might interfere with the study
- Participated in any investigational study within 30 days prior to screening
- Systemic medication that could have a substantial effect on IOP within 30 days prior to screening or anticipated during the study
- Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Data sourced from ClinicalTrials.gov (NCT03310580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.