Status:
COMPLETED
Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Aerie Pharmaceuticals
Conditions:
Primary Open Angle Glaucoma or Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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 \< 30 mmHg in both eyes at screening
- OAG eyes - unmedicated IOP \>/= 15 mmHg and \< 35 mmHg at 2 qualification visits at 08:00, 10:00 and 16:00
- OHT eyes - unmedicated IOP \>/= 22 mmHg and \< 35mmHg at 08:00, 10:00 and 16:00
- Best corrected visual acuity + 1.0 logMAR or better by ETDRS in each eye
- Able to give signed informed consent and follow instructions
Exclusion
- Clinically significant ocular disease
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma or narrow angles
- Intraocular pressure \>/=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
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2018
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03310580
Start Date
November 15 2017
End Date
October 25 2018
Last Update
December 23 2019
Active Locations (40)
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1
Arizona Eye Center
Chandler, Arizona, United States, 85224
2
Arizona Glaucoma Specialists
Phoenix, Arizona, United States, 85050
3
Milton M. Hom, OD FAAO FACAAISc
Azusa, California, United States, 91702
4
Havana Research Institute
Burbank, California, United States, 91506