A Single-masked, Randomized, Multi-center, Parallel-group, 4-week Study Evaluating the Efficacy and Safety of Once Daily Netarsudil Ophthalmic Solution 0.02% Compared to Twice Daily Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% in Japanese Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Overview
- Phase
- Phase 3
- Intervention
- Netarsudil ophthalmic solution 0.02%
- Conditions
- Primary Open Angle Glaucoma
- Sponsor
- Aerie Pharmaceuticals
- Enrollment
- 245
- Locations
- 1
- Primary Endpoint
- Intraocular Pressure (IOP)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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 Primary Open-Angle Glaucoma or Ocular Hypertension Over A 4-Week Period.
Investigators
Eligibility 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 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
Exclusion Criteria
- •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
Arms & Interventions
Netarsudil ophthalmic solution 0.02% and netarsudil ophthalmic solution vehicle
1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye.
Intervention: Netarsudil ophthalmic solution 0.02%
Ripasudil hydrochloride hydrate ophthalmic solution 0.4%
1 drop ripasudil twice daily in the morning and evening in each eye.
Intervention: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%
Outcomes
Primary Outcomes
Intraocular Pressure (IOP)
Time Frame: 29 Days
Comparison of both groups mean diurnal IOP at Week 4 (Day 29). IOP will be measured by Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Mean diurnal IOP was calculated as the average of 3 IOP values across 09:00, 11:00 and 16:00 time points.
Secondary Outcomes
- Mean Change IOP From Baseline at Days 8, 15, 29(Baseline (Day 1), Days 8, 15, 29)
- IOP at Weeks 1 and 2(Day 8, Day 15)