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

Ocular Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04620135
• Other study ID #: AR-13324-CS305
• Status: Completed
• Phase: Phase 3
• Start date: November 30, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: February 2023
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: July 30, 2021
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

Drug:
• Netarsudil ophthalmic solution 0.02%
Topical sterile ophthalmic solution Other Name: Rhopressa®
• Ripasudil hydrochloride hydrate ophthalmic solution 0.4%
Other Name: Glanatec®

Locations

Country	Name	City	State
Japan	Seijo Clinic	Setagaya-Ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP)	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.	29 Days
Secondary	IOP at Weeks 1 and 2	Mean diurnal IOP as measured in mmHg at each post-treatment visit.	Day 8, Day 15
Secondary	Mean Change IOP From Baseline at Days 8, 15, 29	Mean change from baseline in mean diurnal IOP as measured in mmHg at each post-treatment visit.	Baseline (Day 1), Days 8, 15, 29