Last updated: February 1, 2023
Sponsor: Aerie Pharmaceuticals
Overall Status: Completed
Phase
3
Condition
Open Angle Glaucoma
Ocular Hypertension
Stress
Treatment
N/AClinical Study ID
NCT04620135
AR-13324-CS305
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 20 years of age or older
- Diagnosis of POAG or OHT in both eyes (POAG in one eye and OHT in the fellow eye wasacceptable)
- Medicated intraocular pressure (IOP) ≥ 14 mmHg in at least one eye and < 30 mmHg inboth eyes at screening visit
- For POAG eyes, unmedicated (post washout) IOP ≥ 15 mmHg and < 35 mmHg in the study eyeat 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visitIOP ≥ 15 mmHg and < 35 mmHg at 11:00 and 16:00 hour (in the same eye).
- For OHT eyes, unmedicated (post washout) IOP ≥ 22 mmHg and < 35 mmHg in the study eyeat 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visitIOP ≥ 22 mmHg and < 35 mmHg at 11:00 and 16:00 hours (in the same eye)
- Best-corrected visual acuity (BCVA) +0.7 log MAR or better (20/100 Snellen or betteror 0.20 or better in decimal unit) in each eye
- Willingness and ability to give signed informed consent and follow study instructions
Exclusion
Exclusion Criteria:
- Clinically significant ocular disease
- Retinal diseases that may progress during the study period
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closureglaucoma, or narrow angles
- Previous glaucoma intraocular surgery
- Refractive surgery in either eye
- Ocular hyperemia score of moderate (+2) or severe (+3) at Qualification Visit #2
- Ocular trauma
- Ocular infection or inflammation
- Any corneal disease that may confound assessment
- Evidence of corneal deposits or cornea verticillata
- Known hypersensitivity to any component of netarsudil ophthalmic solution 0.02%,ripasudil hydrochloride hydrate ophthalmic solution 0.4%, or to topical anesthetic.
- Mean central corneal thickness >620 um
- Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g.keratoconus)
- Cannot demonstrate proper delivery of the eye drop
- Clinically significant systemic disease
- Participation in any investigational study within 30 days prior to screening
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, ornot using a medically acceptable form of birth control.
Study Design
Total Participants: 245
Study Start date:
November 30, 2020
Estimated Completion Date:
July 30, 2021
Connect with a study center
Seijo Clinic
Setagaya-Ku, Tokyo
JapanSite Not Available

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