Clinical trial NCT04620135: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Keywords: Glaucoma, Primary Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-11-06
Enrollment: 245
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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.

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 29 Days
Secondary outcomes:
measure: IOP at Weeks 1 and 2
timeFrame: Day 8, Day 15
measure: Mean Change IOP From Baseline at Days 8, 15, 29
timeFrame: Baseline (Day 1), Days 8, 15, 29
Other outcomes:
Locations:
city: Setagaya-Ku
country: Japan
facility: Seijo Clinic
state: Tokyo
Study officials:
affiliation: Aerie Pharmaceuticals
name: Joella Kittrell
role: STUDY_DIRECTOR
References: