Efficacy and Safety Study of Netarsudil 0.02% Ophthalmic Solution Compared to Ripasudil Hydrochloride Hydrate 0.4% Ophthalmic Solution in Japanese Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Aerie Pharmaceuticals
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
20 years of age or older
Diagnosis of POAG or OHT in both eyes (POAG in one eye and OHT in the fellow eye was acceptable)
Medicated intraocular pressure (IOP) ≥ 14 mmHg in at least one eye and \< 30 mmHg in both eyes at screening visit
For POAG eyes, unmedicated (post washout) IOP ≥ 15 mmHg and \< 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 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 eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 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 better or 0.20 or better in decimal unit) in each eye
Willingness and ability to give signed informed consent and follow study instructions
You may not be if
Clinically significant ocular disease
Retinal diseases that may progress during the study period
Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, 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, or not using a medically acceptable form of birth control.
Clareo Health | Efficacy and Safety Study of Netarsudil 0.02% Ophthalmic Solution Compared to Ripasudil Hydrochloride Hydrate 0.4% Ophthalmic Solution in Japanese Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
