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Efficacy and Systemic Safety of Netarsudil 0.01%, 0.02%, 0.04% Relative to Placebo in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan

A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety, Ocular Hypotensive Efficacy and Optimum Dose Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03844945
Enrollment
215
Registered
2019-02-19
Start date
2019-03-19
Completion date
2019-09-19
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Open Angle Glaucoma

Keywords

Glaucoma, Ocular Hypertension, Open-Angle Glaucoma

Brief summary

Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan

Interventions

DRUGNetarsudil Ophthalmic Solution 0.01%

Topical sterile ophthalmic solution

DRUGNetarsudil Ophthalmic Solution 0.02%

Topical sterile ophthalmic solution

DRUGNetarsudil Ophthalmic Solution 0.04%

Topical sterile ophthalmic solution

OTHERNetarsudil Ophthalmic Solution Placebo

Topical sterile ophthalmic solution

Sponsors

Aerie Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Must be 20 years of age or older 2. Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG in one eye and OHT in the fellow eye is acceptable) 3. BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent 4. Able and willing to give signed informed consent and following study instructions

Exclusion criteria

1. Clinically significant ocular diseases 2. Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles 3. Previous glaucoma intraocular surgery 4. Refractive surgery in either eye 5. Ocular trauma 6. Ocular infection or inflammation 7. Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic solution 8. Cannot demonstrate proper delivery of the eye drop 9. Clinically significant abnormalities in screen lab tests 10. Clinically significant systemic disease 11. Participation in any investigational study within 30 days of screening 12. Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

Design outcomes

Primary

MeasureTime frameDescription
Intraocular Pressure (IOP)29 DaysMean diurnal IOP within a treatment by Goldman Applanation Tonometry

Countries

Japan

Participant flow

Recruitment details

Participants were recruited at 25 clinical trial sites in Japan.

Pre-assignment details

Prior to enrollment, adult participants were to have a Screening Visit and 2 Qualification Visits to allow for washout of ocular hypotensive medication if needed.

Participants by arm

ArmCount
Netarsudil Ophthalmic Solution 0.01%
1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution 0.01%: Topical sterile ophthalmic solution
55
Netarsudil Ophthalmic Solution 0.02%
1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution
54
Netarsudil Ophthalmic Solution 0.04%
1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution
51
Netarsudil Ophthalmic Solution Placebo
1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution Placebo: Topical sterile ophthalmic solution
55
Total215

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyAdverse Event1140
Overall StudyLack of Efficacy0001
Overall StudyWithdrawal by Subject0010

Baseline characteristics

CharacteristicNetarsudil Ophthalmic Solution 0.01%TotalNetarsudil Ophthalmic Solution PlaceboNetarsudil Ophthalmic Solution 0.04%Netarsudil Ophthalmic Solution 0.02%
Age, Continuous62.7 years
STANDARD_DEVIATION 14.62
63.35 years
STANDARD_DEVIATION 13.23
64.6 years
STANDARD_DEVIATION 12.58
62 years
STANDARD_DEVIATION 13.56
64.1 years
STANDARD_DEVIATION 12.16
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
55 Participants215 Participants55 Participants51 Participants54 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Female
36 Participants123 Participants31 Participants27 Participants29 Participants
Sex: Female, Male
Male
19 Participants92 Participants24 Participants24 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 550 / 540 / 510 / 55
other
Total, other adverse events
21 / 5527 / 5436 / 515 / 55
serious
Total, serious adverse events
0 / 550 / 540 / 510 / 55

Outcome results

Primary

Intraocular Pressure (IOP)

Mean diurnal IOP within a treatment by Goldman Applanation Tonometry

Time frame: 29 Days

Population: Intent to treat (ITT) population

ArmMeasureGroupValue (MEAN)Dispersion
Netarsudil Ophthalmic Solution 0.01%Intraocular Pressure (IOP)Day 120.5 mmHgStandard Deviation 2.8362
Netarsudil Ophthalmic Solution 0.01%Intraocular Pressure (IOP)Day 816.2 mmHgStandard Deviation 2.568
Netarsudil Ophthalmic Solution 0.01%Intraocular Pressure (IOP)Day 1515.9 mmHgStandard Deviation 2.703
Netarsudil Ophthalmic Solution 0.01%Intraocular Pressure (IOP)Day 2916.3 mmHgStandard Deviation 2.609
Netarsudil Ophthalmic Solution 0.02%Intraocular Pressure (IOP)Day 815.9 mmHgStandard Deviation 2.673
Netarsudil Ophthalmic Solution 0.02%Intraocular Pressure (IOP)Day 120.3 mmHgStandard Deviation 2.8039
Netarsudil Ophthalmic Solution 0.02%Intraocular Pressure (IOP)Day 1515.6 mmHgStandard Deviation 2.573
Netarsudil Ophthalmic Solution 0.02%Intraocular Pressure (IOP)Day 2915.4 mmHgStandard Deviation 2.411
Netarsudil Ophthalmic Solution 0.04%Intraocular Pressure (IOP)Day 2916.2 mmHgStandard Deviation 4.496
Netarsudil Ophthalmic Solution 0.04%Intraocular Pressure (IOP)Day 1515.7 mmHgStandard Deviation 4.19
Netarsudil Ophthalmic Solution 0.04%Intraocular Pressure (IOP)Day 120.8 mmHgStandard Deviation 3.2037
Netarsudil Ophthalmic Solution 0.04%Intraocular Pressure (IOP)Day 815.7 mmHgStandard Deviation 4.014
Netarsudil Ophthalmic Solution PlaceboIntraocular Pressure (IOP)Day 819.8 mmHgStandard Deviation 4.059
Netarsudil Ophthalmic Solution PlaceboIntraocular Pressure (IOP)Day 1519.3 mmHgStandard Deviation 3.702
Netarsudil Ophthalmic Solution PlaceboIntraocular Pressure (IOP)Day 2919.3 mmHgStandard Deviation 3.728
Netarsudil Ophthalmic Solution PlaceboIntraocular Pressure (IOP)Day 121.1 mmHgStandard Deviation 3.7023
p-value: <0.0001ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026