Trial Outcomes & Findings for Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension (NCT NCT02674854)
NCT ID: NCT02674854
Last Updated: 2019-05-21
Results Overview
Mean intraocular pressure(IOP) at 08:00, 10:00 and 16:00 hours, at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
750 participants
Primary outcome timeframe
3 months
Results posted on
2019-05-21
Participant Flow
Participant milestones
| Measure |
PG324 Ophthalmic Solution 0.02%/0.005%
1 drop daily in the evening (PM) in both eyes (OU)
|
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
1 drop daily in the evening (PM) in both eyes (OU)
|
Latanoprost Ophthalmic Solution 0.005%
1 drop daily in the evening (PM) in both eyes (OU)
|
|---|---|---|---|
|
Overall Study
STARTED
|
245
|
255
|
250
|
|
Overall Study
COMPLETED
|
221
|
228
|
236
|
|
Overall Study
NOT COMPLETED
|
24
|
27
|
14
|
Reasons for withdrawal
| Measure |
PG324 Ophthalmic Solution 0.02%/0.005%
1 drop daily in the evening (PM) in both eyes (OU)
|
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
1 drop daily in the evening (PM) in both eyes (OU)
|
Latanoprost Ophthalmic Solution 0.005%
1 drop daily in the evening (PM) in both eyes (OU)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
17
|
15
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
4
|
|
Overall Study
No-compliant subject
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
0
|
|
Overall Study
Disallowed Concurrent Medication
|
2
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Subject missed V6.2
|
1
|
0
|
0
|
Baseline Characteristics
Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
PG324 Ophthalmic Solution
n=245 Participants
1 drop daily in the evening (PM) in both eyes (OU)
|
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
n=255 Participants
1 drop daily in the evening (PM) in both eyes (OU)
|
Latanoprost Ophthalmic Solution 0.005%
n=250 Participants
1 drop daily in the evening (PM) in both eyes (OU)
|
Total
n=750 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
|
118 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
339 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
127 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
411 Participants
n=4 Participants
|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 10.58 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 11.41 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 11.26 • n=4 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
449 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
301 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
200 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
602 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
74 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
229 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
161 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
489 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intent to treat (ITT) population with Monte Carlo Markov Chain (MCMC) imputation
Mean intraocular pressure(IOP) at 08:00, 10:00 and 16:00 hours, at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry.
Outcome measures
| Measure |
PG324 Ophthalmic Solution
n=245 Participants
1 drop daily in the evening (PM) in both eyes (OU)
|
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
n=255 Participants
1 drop daily in the evening (PM) in both eyes (OU)
|
Latanoprost Ophthalmic Solution 0.005%
n=250 Participants
1 drop daily in the evening (PM) in both eyes (OU)
|
|---|---|---|---|
|
Intraocular Pressure (IOP)
Day 1, 0800 hours
|
24.69 mmHg
Standard Deviation 3.422
|
24.66 mmHg
Standard Deviation 3.148
|
24.75 mmHg
Standard Deviation 3.240
|
|
Intraocular Pressure (IOP)
Day 1, 1000 hours
|
23.33 mmHg
Standard Deviation 3.399
|
23.40 mmHg
Standard Deviation 3.538
|
23.23 mmHg
Standard Deviation 3.339
|
|
Intraocular Pressure (IOP)
Day 1, 1600 hours
|
22.37 mmHg
Standard Deviation 3.492
|
22.76 mmHg
Standard Deviation 3.558
|
22.59 mmHg
Standard Deviation 3.451
|
|
Intraocular Pressure (IOP)
Day 15, 0800 hours
|
16.06 mmHg
Standard Deviation 3.370
|
19.35 mmHg
Standard Deviation 4.279
|
18.10 mmHg
Standard Deviation 3.375
|
|
Intraocular Pressure (IOP)
Day 15, 1000 hours
|
15.31 mmHg
Standard Deviation 3.272
|
17.99 mmHg
Standard Deviation 3.909
|
17.61 mmHg
Standard Deviation 3.264
|
|
Intraocular Pressure (IOP)
Day 15, 1600 hours
|
15.16 mmHg
Standard Deviation 3.032
|
17.53 mmHg
Standard Deviation 3.772
|
17.08 mmHg
Standard Deviation 3.283
|
|
Intraocular Pressure (IOP)
Day 43, 0800 hours
|
16.43 mmHg
Standard Deviation 3.717
|
19.52 mmHg
Standard Deviation 4.273
|
17.93 mmHg
Standard Deviation 3.586
|
|
Intraocular Pressure (IOP)
Day 43, 1000 hours
|
15.54 mmHg
Standard Deviation 3.533
|
18.40 mmHg
Standard Deviation 3.810
|
17.35 mmHg
Standard Deviation 3.224
|
|
Intraocular Pressure (IOP)
Day 43, 1600 hours
|
15.45 mmHg
Standard Deviation 3.525
|
17.95 mmHg
Standard Deviation 3.776
|
17.09 mmHg
Standard Deviation 3.271
|
|
Intraocular Pressure (IOP)
Day 90, 0800 hours
|
16.45 mmHg
Standard Deviation 3.572
|
19.72 mmHg
Standard Deviation 4.419
|
17.98 mmHg
Standard Deviation 3.400
|
|
Intraocular Pressure (IOP)
Day 90, 1000 hours
|
15.58 mmHg
Standard Deviation 3.307
|
18.30 mmHg
Standard Deviation 3.846
|
17.48 mmHg
Standard Deviation 3.366
|
|
Intraocular Pressure (IOP)
Day 90, 1600 hours
|
15.52 mmHg
Standard Deviation 3.210
|
17.94 mmHg
Standard Deviation 3.627
|
17.14 mmHg
Standard Deviation 3.044
|
Adverse Events
PG324 Ophthalmic Solution
Serious events: 2 serious events
Other events: 157 other events
Deaths: 0 deaths
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Serious events: 6 serious events
Other events: 143 other events
Deaths: 1 deaths
Latanoprost Ophthalmic Solution 0.005%
Serious events: 5 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PG324 Ophthalmic Solution
n=244 participants at risk
1 drop daily in the evening (PM) in both eyes (OU)
|
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
n=255 participants at risk
1 drop daily in the evening (PM) in both eyes (OU)
|
Latanoprost Ophthalmic Solution 0.005%
n=251 participants at risk
1 drop daily in the evening (PM) in both eyes (OU)
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.41%
1/244 • Number of events 1 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.78%
2/255 • Number of events 2 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/251 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/244 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.39%
1/255 • Number of events 1 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.40%
1/251 • Number of events 1 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/244 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.39%
1/255 • Number of events 1 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/251 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Cardiac disorders
Coronary Artery Disease
|
0.41%
1/244 • Number of events 1 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/255 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/251 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Infections and infestations
Bronchitis
|
0.00%
0/244 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.39%
1/255 • Number of events 1 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/251 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/244 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/255 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.40%
1/251 • Number of events 1 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Infections and infestations
Pneumonia
|
0.00%
0/244 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/255 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.40%
1/251 • Number of events 1 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/244 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/255 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.40%
1/251 • Number of events 1 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/244 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/255 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.40%
1/251 • Number of events 1 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Nervous system disorders
Vertebral Artery Stenosis
|
0.00%
0/244 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.39%
1/255 • Number of events 1 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/251 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Psychiatric disorders
Mental Status Changes
|
0.41%
1/244 • Number of events 1 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/255 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/251 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/244 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.39%
1/255 • Number of events 1 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/251 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
Other adverse events
| Measure |
PG324 Ophthalmic Solution
n=244 participants at risk
1 drop daily in the evening (PM) in both eyes (OU)
|
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
n=255 participants at risk
1 drop daily in the evening (PM) in both eyes (OU)
|
Latanoprost Ophthalmic Solution 0.005%
n=251 participants at risk
1 drop daily in the evening (PM) in both eyes (OU)
|
|---|---|---|---|
|
Eye disorders
Conjunctival Hyperaemia
|
51.6%
126/244 • Number of events 126 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
40.0%
102/255 • Number of events 102 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
20.3%
51/251 • Number of events 51 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Eye disorders
Cornea Verticillata
|
13.1%
32/244 • Number of events 32 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
9.8%
25/255 • Number of events 25 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/251 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Eye disorders
Conjunctival Haemorrhage
|
5.7%
14/244 • Number of events 14 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
6.7%
17/255 • Number of events 17 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.80%
2/251 • Number of events 2 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Eye disorders
Corneal Disorder
|
5.7%
14/244 • Number of events 14 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
4.7%
12/255 • Number of events 12 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.00%
0/251 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
General disorders
Instillation Site Pain
|
17.2%
42/244 • Number of events 42 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
9.0%
23/255 • Number of events 23 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
6.0%
15/251 • Number of events 15 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
General disorders
Instillation Site Discomfort
|
6.1%
15/244 • Number of events 15 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
6.3%
16/255 • Number of events 16 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
0.80%
2/251 • Number of events 2 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
|
Investigations
Vital Dye Staining Cornea Present
|
3.3%
8/244 • Number of events 8 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
5.1%
13/255 • Number of events 13 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
4.0%
10/251 • Number of events 10 • Adverse event data was collected during the 90 day treatment period.
Safety population, defined as all randomized subjects who received at least 1 dose of investigational product. One subject was randomized to PG324 ophthalmic solution; however, the subject received latanoprost ophthalmic solution 0.005%, resulting in 1 less subject counted in the safety population for PG324 ophthalmic solution and 1 additional subject in the safety population for latanoprost ophthalmic solution 0.005% relative to the numbers in the respective randomized populations
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place