Trial Outcomes & Findings for Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension (NCT NCT03310580)
NCT ID: NCT03310580
Last Updated: 2019-12-23
Results Overview
Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
28 Days
Results posted on
2019-12-23
Participant Flow
Participant milestones
| Measure |
AR-13324 Ophthalmic Solution 0.02%
AR-13324 Ophthalmic Solution 0.02% : Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
|
AR-13324 Ophthalmic Solution 0.04%
AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
|
Placebo Comparator
AR-13324 Ophthalmic Solution Placebo: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
12
|
|
Overall Study
COMPLETED
|
15
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
AR-13324 Ophthalmic Solution 0.02%
AR-13324 Ophthalmic Solution 0.02% : Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
|
AR-13324 Ophthalmic Solution 0.04%
AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
|
Placebo Comparator
AR-13324 Ophthalmic Solution Placebo: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
AR-13324 Ophthalmic Solution 0.02%
n=14 Participants
AR-13324 Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
|
AR-13324 Ophthalmic Solution 0.04%
n=14 Participants
AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
|
Placebo Comparator
n=12 Participants
AR-13324 Ophthalmic Solution Placebo: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 20.32 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 12.12 • n=7 Participants
|
65.6 years
STANDARD_DEVIATION 14.98 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 15.95 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Japanese 1st Generation
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Japanese 2nd Generation
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
12 participants
n=5 Participants
|
40 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: Intent to treat (ITT) population
Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).
Outcome measures
| Measure |
AR-13324 Ophthalmic Solution 0.02%
n=14 Participants
AR-13324 ophthalmic solution 0.02%; 1 drop daily to each eye for 28 days
AR-13324 Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution
|
AR-13324 Ophthalmic Solution 0.04%
n=14 Participants
AR-13324 ophthalmic solution 0.04%; 1 drop daily to each eye for 28 days
AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution
|
Placebo Comparator
n=12 Participants
AR-13324 ophthalmic solution placebo; 1 drop daily to each eye for 28 days
AR-13324 Ophthalmic Solution Placebo; Topical sterile ophthalmic solution
|
|---|---|---|---|
|
Mean Diurnal IOP (Intraocular Pressure) (mmHg)
|
14.35 mmHg
Standard Error 0.549
|
14.33 mmHg
Standard Error 0.567
|
17.32 mmHg
Standard Error 0.576
|
SECONDARY outcome
Timeframe: 28 DaysPopulation: Exposure to study medication in days for all treatment groups
Exposure to study medication in days for all treatment groups
Outcome measures
| Measure |
AR-13324 Ophthalmic Solution 0.02%
n=15 Participants
AR-13324 ophthalmic solution 0.02%; 1 drop daily to each eye for 28 days
AR-13324 Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution
|
AR-13324 Ophthalmic Solution 0.04%
n=14 Participants
AR-13324 ophthalmic solution 0.04%; 1 drop daily to each eye for 28 days
AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution
|
Placebo Comparator
n=12 Participants
AR-13324 ophthalmic solution placebo; 1 drop daily to each eye for 28 days
AR-13324 Ophthalmic Solution Placebo; Topical sterile ophthalmic solution
|
|---|---|---|---|
|
Extent of Exposure
|
27.9 Days
Standard Deviation 1.91
|
26.8 Days
Standard Deviation 7.56
|
27.4 Days
Standard Deviation 2.23
|
Adverse Events
AR-13324 Ophthalmic Solution 0.02%
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
AR-13324 Ophthalmic Solution 0.04%
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AR-13324 Ophthalmic Solution 0.02%
n=15 participants at risk
AR-13324 Ophthalmic Solution 0.02%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
|
AR-13324 Ophthalmic Solution 0.04%
n=14 participants at risk
AR-13324 Ophthalmic Solution 0.04%: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
|
Placebo Comparator
n=12 participants at risk
AR-13324 Ophthalmic Solution Placebo: Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
|
|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
66.7%
10/15 • Number of events 10 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
71.4%
10/14 • Number of events 10 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
0.00%
0/12 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/15 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
14.3%
2/14 • Number of events 2 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
8.3%
1/12 • Number of events 1 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
|
Eye disorders
Conjunctival hemorrhage
|
0.00%
0/15 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
14.3%
2/14 • Number of events 2 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
0.00%
0/12 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
|
Eye disorders
Dry eye
|
0.00%
0/15 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
7.1%
1/14 • Number of events 1 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
8.3%
1/12 • Number of events 1 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
|
Eye disorders
vision blurred
|
13.3%
2/15 • Number of events 2 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
0.00%
0/14 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
0.00%
0/12 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
|
Eye disorders
Eyelid margin crusting
|
0.00%
0/15 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
7.1%
1/14 • Number of events 1 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
0.00%
0/12 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/15 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
7.1%
1/14 • Number of events 1 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
0.00%
0/12 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
|
General disorders
Instillation site foreign body sensation
|
6.7%
1/15 • Number of events 1 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
0.00%
0/14 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
0.00%
0/12 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
|
General disorders
Instillation site pain
|
0.00%
0/15 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
7.1%
1/14 • Number of events 1 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
0.00%
0/12 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/15 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
0.00%
0/14 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
8.3%
1/12 • Number of events 1 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/15 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
0.00%
0/14 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
8.3%
1/12 • Number of events 1 • Adverse Event data was collected during the course of the study of 28 days and after 30 days safety follow up
Safety population is defined as all randomized subjects who have received at least 1 dose of study medication.
|
Additional Information
Nancy Ramirez-Davis, Director, Global Clinical Operations
Aerie Pharmaceuticals, Inc.
Phone: (908) 947-3543
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place