Safety and Efficacy Study of Netarsudil 0.02% Ophthalmic Solution Compared to Ripasudil Hydrochloride Hydrate 0.4% Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Trial end date: 2021-07-30
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 3 Study Comparing the Efficacy and Safety of Netarsudil Ophthalmic Solution 0.02% QD to Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% BID, for Treatment of Open-Angle Glaucoma or Ocular Hypertension Over A 4-Week Period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aerie Pharmaceuticals
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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 is acceptable)

• 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

Exclusion Criteria:

• Clinically significant ocular disease

• Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles

• Previous glaucoma intraocular surgery

• Refractive surgery in either eye

• Ocular trauma

• Ocular infection

• Any corneal disease

• Known hypersensitivity to any component of netarsudil ophthalmic solution 0.02%, ripasudil hydrochloride hydrate ophthalmic solution 0.4%, or to topical anesthetic.

• 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.