Trial Outcomes & Findings for 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 (NCT NCT04620135)
NCT ID: NCT04620135
Last Updated: 2023-02-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
245 participants
Primary outcome timeframe
29 Days
Results posted on
2023-02-27
Participant Flow
Recruitment took place at 27 clinic sites in Japan starting on 30Nov2020 with last subject last visit on 30July2021.
Subjects were required to washout of their pre-study ocular hypotensive medication for a prescribed period as specified in the protocol prior to attending Qualification Visit #1.
Participant milestones
| Measure |
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.
Netarsudil ophthalmic solution 0.02%: Topical sterile ophthalmic solution Other Name: Rhopressa®
|
Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%
1 drop ripasudil twice daily in the morning and evening in each eye.
Ripasudil hydrochloride hydrate ophthalmic solution 0.4%: Other Name: Glanatec®
|
|---|---|---|
|
Intent-to-Treat (ITT) Population
STARTED
|
122
|
123
|
|
Intent-to-Treat (ITT) Population
COMPLETED
|
118
|
120
|
|
Intent-to-Treat (ITT) Population
NOT COMPLETED
|
4
|
3
|
|
Per-Protocol (PP) Population
STARTED
|
121
|
122
|
|
Per-Protocol (PP) Population
COMPLETED
|
117
|
119
|
|
Per-Protocol (PP) Population
NOT COMPLETED
|
4
|
3
|
|
Safety Population
STARTED
|
122
|
123
|
|
Safety Population
COMPLETED
|
118
|
120
|
|
Safety Population
NOT COMPLETED
|
4
|
3
|
|
Study Completion
STARTED
|
122
|
123
|
|
Study Completion
COMPLETED
|
118
|
120
|
|
Study Completion
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
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.
Netarsudil ophthalmic solution 0.02%: Topical sterile ophthalmic solution Other Name: Rhopressa®
|
Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%
1 drop ripasudil twice daily in the morning and evening in each eye.
Ripasudil hydrochloride hydrate ophthalmic solution 0.4%: Other Name: Glanatec®
|
|---|---|---|
|
Study Completion
Adverse Event
|
2
|
3
|
|
Study Completion
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle
n=122 Participants
1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye.
Netarsudil ophthalmic solution 0.02%: Topical sterile ophthalmic solution Other Name: Rhopressa®
|
Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%
n=123 Participants
1 drop ripasudil twice daily in the morning and evening in each eye.
Ripasudil hydrochloride hydrate ophthalmic solution 0.4%: Other Name: Glanatec®
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age Category · < 65 years
|
63 Participants
n=122 Participants
|
60 Participants
n=123 Participants
|
123 Participants
n=245 Participants
|
|
Age, Customized
Age Category · >= 65 years
|
59 Participants
n=122 Participants
|
63 Participants
n=123 Participants
|
122 Participants
n=245 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=122 Participants
|
66 Participants
n=123 Participants
|
144 Participants
n=245 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=122 Participants
|
57 Participants
n=123 Participants
|
101 Participants
n=245 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Study Eye Diagnosis
Ocular Hypertension
|
32 Participants
n=122 Participants
|
35 Participants
n=123 Participants
|
67 Participants
n=245 Participants
|
|
Study Eye Diagnosis
Primary Open Angle Glaucoma
|
90 Participants
n=122 Participants
|
88 Participants
n=123 Participants
|
178 Participants
n=245 Participants
|
PRIMARY outcome
Timeframe: 29 DaysPopulation: The intent-to-treat (ITT) population was used for the primary analysis of the efficacy variables and included all randomized subjects (as randomized) who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle
n=122 Participants
1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye.
Netarsudil ophthalmic solution 0.02%: Topical sterile ophthalmic solution Other Name: Rhopressa®
|
Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%
n=123 Participants
1 drop ripasudil twice daily in the morning and evening in each eye.
Ripasudil hydrochloride hydrate ophthalmic solution 0.4%: Other Name: Glanatec®
|
|---|---|---|
|
Intraocular Pressure (IOP)
|
15.96 mmHg
Standard Error 0.157
|
17.71 mmHg
Standard Error 0.155
|
SECONDARY outcome
Timeframe: Day 8, Day 15Population: ITT
Mean diurnal IOP as measured in mmHg at each post-treatment visit.
Outcome measures
| Measure |
Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle
n=122 Participants
1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye.
Netarsudil ophthalmic solution 0.02%: Topical sterile ophthalmic solution Other Name: Rhopressa®
|
Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%
n=123 Participants
1 drop ripasudil twice daily in the morning and evening in each eye.
Ripasudil hydrochloride hydrate ophthalmic solution 0.4%: Other Name: Glanatec®
|
|---|---|---|
|
IOP at Weeks 1 and 2
Mean diurnal IOP at Weeks 1 (Days 8)
|
16.28 mmHg
Standard Error 0.143
|
17.87 mmHg
Standard Error 0.141
|
|
IOP at Weeks 1 and 2
Mean diurnal IOP at Weeks 2 (Days 15)
|
16.02 mmHg
Standard Error 0.168
|
17.83 mmHg
Standard Error 0.166
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 8, 15, 29Population: ITT
Mean change from baseline in mean diurnal IOP as measured in mmHg at each post-treatment visit.
Outcome measures
| Measure |
Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle
n=122 Participants
1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye.
Netarsudil ophthalmic solution 0.02%: Topical sterile ophthalmic solution Other Name: Rhopressa®
|
Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%
n=123 Participants
1 drop ripasudil twice daily in the morning and evening in each eye.
Ripasudil hydrochloride hydrate ophthalmic solution 0.4%: Other Name: Glanatec®
|
|---|---|---|
|
Mean Change IOP From Baseline at Days 8, 15, 29
Baseline IOP mean diurnal IOP
|
20.475 mmHg
Standard Error 0.2510
|
20.830 mmHg
Standard Error 0.3198
|
|
Mean Change IOP From Baseline at Days 8, 15, 29
V4: Week 1 (Day 8) Change from Baseline
|
-4.341 mmHg
Standard Error 0.1603
|
-2.814 mmHg
Standard Error 0.1397
|
|
Mean Change IOP From Baseline at Days 8, 15, 29
V5: Week 2 (Day 15) Change from Baseline
|
-4.601 mmHg
Standard Error 0.1728
|
-2.852 mmHg
Standard Error 0.1759
|
|
Mean Change IOP From Baseline at Days 8, 15, 29
V6: Week 4 (Day 29) Change from Baseline
|
-4.653 mmHg
Standard Error 0.1701
|
-2.983 mmHg
Standard Error 0.1622
|
Adverse Events
Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle
Serious events: 0 serious events
Other events: 73 other events
Deaths: 0 deaths
Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%
Serious events: 2 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle
n=122 participants at risk
1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye.
Netarsudil ophthalmic solution 0.02%: Topical sterile ophthalmic solution Other Name: Rhopressa®
|
Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%
n=123 participants at risk
1 drop ripasudil twice daily in the morning and evening in each eye.
Ripasudil hydrochloride hydrate ophthalmic solution 0.4%: Other Name: Glanatec®
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Infections and infestations
|
0.00%
0/122 • Volunteered or solicited AEs were collected from the time the subject received the first dose of study medication until Week 4 (Day 29) or study discontinuation. Unresolved AEs at the time of study exit were followed with proper medical care until the event was considered resolved or stabilized, the subject was lost to follow-up, or another resolution to the event was identified.
An overall summary was presented including the number of treatment emergent AEs (TEAEs) and the number and percentage of subjects who experienced at least one TEAE, as well as categorized overall summaries for TEAEs (ocular and non-ocular), TE-SAEs, treatment-related TEAEs and TE-SAEs, TEAEs by maximum severity and by relationship to study drug, TEAEs leading to treatment or study discontinuation, and TEAEs resulting in death.
|
0.81%
1/123 • Number of events 1 • Volunteered or solicited AEs were collected from the time the subject received the first dose of study medication until Week 4 (Day 29) or study discontinuation. Unresolved AEs at the time of study exit were followed with proper medical care until the event was considered resolved or stabilized, the subject was lost to follow-up, or another resolution to the event was identified.
An overall summary was presented including the number of treatment emergent AEs (TEAEs) and the number and percentage of subjects who experienced at least one TEAE, as well as categorized overall summaries for TEAEs (ocular and non-ocular), TE-SAEs, treatment-related TEAEs and TE-SAEs, TEAEs by maximum severity and by relationship to study drug, TEAEs leading to treatment or study discontinuation, and TEAEs resulting in death.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.00%
0/122 • Volunteered or solicited AEs were collected from the time the subject received the first dose of study medication until Week 4 (Day 29) or study discontinuation. Unresolved AEs at the time of study exit were followed with proper medical care until the event was considered resolved or stabilized, the subject was lost to follow-up, or another resolution to the event was identified.
An overall summary was presented including the number of treatment emergent AEs (TEAEs) and the number and percentage of subjects who experienced at least one TEAE, as well as categorized overall summaries for TEAEs (ocular and non-ocular), TE-SAEs, treatment-related TEAEs and TE-SAEs, TEAEs by maximum severity and by relationship to study drug, TEAEs leading to treatment or study discontinuation, and TEAEs resulting in death.
|
0.81%
1/123 • Number of events 1 • Volunteered or solicited AEs were collected from the time the subject received the first dose of study medication until Week 4 (Day 29) or study discontinuation. Unresolved AEs at the time of study exit were followed with proper medical care until the event was considered resolved or stabilized, the subject was lost to follow-up, or another resolution to the event was identified.
An overall summary was presented including the number of treatment emergent AEs (TEAEs) and the number and percentage of subjects who experienced at least one TEAE, as well as categorized overall summaries for TEAEs (ocular and non-ocular), TE-SAEs, treatment-related TEAEs and TE-SAEs, TEAEs by maximum severity and by relationship to study drug, TEAEs leading to treatment or study discontinuation, and TEAEs resulting in death.
|
|
General disorders
Treatment-Emergent Serious Adverse Event (TE-SAE)
|
0.00%
0/122 • Volunteered or solicited AEs were collected from the time the subject received the first dose of study medication until Week 4 (Day 29) or study discontinuation. Unresolved AEs at the time of study exit were followed with proper medical care until the event was considered resolved or stabilized, the subject was lost to follow-up, or another resolution to the event was identified.
An overall summary was presented including the number of treatment emergent AEs (TEAEs) and the number and percentage of subjects who experienced at least one TEAE, as well as categorized overall summaries for TEAEs (ocular and non-ocular), TE-SAEs, treatment-related TEAEs and TE-SAEs, TEAEs by maximum severity and by relationship to study drug, TEAEs leading to treatment or study discontinuation, and TEAEs resulting in death.
|
1.6%
2/123 • Number of events 2 • Volunteered or solicited AEs were collected from the time the subject received the first dose of study medication until Week 4 (Day 29) or study discontinuation. Unresolved AEs at the time of study exit were followed with proper medical care until the event was considered resolved or stabilized, the subject was lost to follow-up, or another resolution to the event was identified.
An overall summary was presented including the number of treatment emergent AEs (TEAEs) and the number and percentage of subjects who experienced at least one TEAE, as well as categorized overall summaries for TEAEs (ocular and non-ocular), TE-SAEs, treatment-related TEAEs and TE-SAEs, TEAEs by maximum severity and by relationship to study drug, TEAEs leading to treatment or study discontinuation, and TEAEs resulting in death.
|
Other adverse events
| Measure |
Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle
n=122 participants at risk
1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye.
Netarsudil ophthalmic solution 0.02%: Topical sterile ophthalmic solution Other Name: Rhopressa®
|
Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%
n=123 participants at risk
1 drop ripasudil twice daily in the morning and evening in each eye.
Ripasudil hydrochloride hydrate ophthalmic solution 0.4%: Other Name: Glanatec®
|
|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
54.9%
67/122 • Volunteered or solicited AEs were collected from the time the subject received the first dose of study medication until Week 4 (Day 29) or study discontinuation. Unresolved AEs at the time of study exit were followed with proper medical care until the event was considered resolved or stabilized, the subject was lost to follow-up, or another resolution to the event was identified.
An overall summary was presented including the number of treatment emergent AEs (TEAEs) and the number and percentage of subjects who experienced at least one TEAE, as well as categorized overall summaries for TEAEs (ocular and non-ocular), TE-SAEs, treatment-related TEAEs and TE-SAEs, TEAEs by maximum severity and by relationship to study drug, TEAEs leading to treatment or study discontinuation, and TEAEs resulting in death.
|
62.6%
77/123 • Volunteered or solicited AEs were collected from the time the subject received the first dose of study medication until Week 4 (Day 29) or study discontinuation. Unresolved AEs at the time of study exit were followed with proper medical care until the event was considered resolved or stabilized, the subject was lost to follow-up, or another resolution to the event was identified.
An overall summary was presented including the number of treatment emergent AEs (TEAEs) and the number and percentage of subjects who experienced at least one TEAE, as well as categorized overall summaries for TEAEs (ocular and non-ocular), TE-SAEs, treatment-related TEAEs and TE-SAEs, TEAEs by maximum severity and by relationship to study drug, TEAEs leading to treatment or study discontinuation, and TEAEs resulting in death.
|
|
Eye disorders
Eye irritation
|
5.7%
7/122 • Volunteered or solicited AEs were collected from the time the subject received the first dose of study medication until Week 4 (Day 29) or study discontinuation. Unresolved AEs at the time of study exit were followed with proper medical care until the event was considered resolved or stabilized, the subject was lost to follow-up, or another resolution to the event was identified.
An overall summary was presented including the number of treatment emergent AEs (TEAEs) and the number and percentage of subjects who experienced at least one TEAE, as well as categorized overall summaries for TEAEs (ocular and non-ocular), TE-SAEs, treatment-related TEAEs and TE-SAEs, TEAEs by maximum severity and by relationship to study drug, TEAEs leading to treatment or study discontinuation, and TEAEs resulting in death.
|
5.7%
7/123 • Volunteered or solicited AEs were collected from the time the subject received the first dose of study medication until Week 4 (Day 29) or study discontinuation. Unresolved AEs at the time of study exit were followed with proper medical care until the event was considered resolved or stabilized, the subject was lost to follow-up, or another resolution to the event was identified.
An overall summary was presented including the number of treatment emergent AEs (TEAEs) and the number and percentage of subjects who experienced at least one TEAE, as well as categorized overall summaries for TEAEs (ocular and non-ocular), TE-SAEs, treatment-related TEAEs and TE-SAEs, TEAEs by maximum severity and by relationship to study drug, TEAEs leading to treatment or study discontinuation, and TEAEs resulting in death.
|
Additional Information
Michelle Senchyna, PhD. VP, Clinical Development and Medical Affairs
Aerie Pharmaceuticals Inc.
Phone: +1 908-947-3551
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place