Trial Outcomes & Findings for Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure (NCT NCT02057575)
NCT ID: NCT02057575
Last Updated: 2019-06-04
Results Overview
The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
298 participants
Primary outcome timeframe
Study treatment was administered for 28 days, and outcome measures collected on Day 29
Results posted on
2019-06-04
Participant Flow
Participant milestones
| Measure |
PG324 Ophthalmic Solution 0.01%
PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
PG324 Ophthalmic Solution 0.02%
PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
Latanoprost Ophthalmic Solution 0.005%
Latanoprost Ophthalmic Solution 0.005%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
74
|
73
|
78
|
73
|
|
Overall Study
COMPLETED
|
73
|
69
|
78
|
72
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
0
|
1
|
Reasons for withdrawal
| Measure |
PG324 Ophthalmic Solution 0.01%
PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
PG324 Ophthalmic Solution 0.02%
PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
Latanoprost Ophthalmic Solution 0.005%
Latanoprost Ophthalmic Solution 0.005%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Dissallowed Concurrent Medication
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
Baseline characteristics by cohort
| Measure |
PG324 Ophthalmic Solution 0.01%
n=74 Participants
PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
PG324 Ophthalmic Solution 0.02%
n=73 Participants
PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
n=78 Participants
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
Latanoprost Ophthalmic Solution 0.005%
n=73 Participants
Latanoprost Ophthalmic Solution 0.005%
1 drop daily in the evening (PM), once daily (QD), both eyes (OU)
|
Total
n=298 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 11.26 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 11.07 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 11.28 • n=5 Participants
|
65.1 years
STANDARD_DEVIATION 12.80 • n=4 Participants
|
64.9 years
STANDARD_DEVIATION 11.57 • n=21 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
175 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
234 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
236 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Study treatment was administered for 28 days, and outcome measures collected on Day 29Population: Modified intent to treat (mITT) population
The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.
Outcome measures
| Measure |
PG324 Ophthalmic Solution 0.01%
n=73 Participants
PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
PG324 Ophthalmic Solution 0.02%
n=72 Participants
PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
Netarsudil (AR-13324) Ophthalmic Solution
n=78 Participants
Netarsudil (AR-13324) Ophthalmic Solution
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
Latanoprost Ophthalmic Solution
n=73 Participants
Latanoprost Ophthalmic Solution
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
|---|---|---|---|---|
|
Intraocular Pressure (IOP)
Day 1, Diurnal Mean
|
25.11 mmHg
Standard Deviation 2.330
|
25.12 mmHg
Standard Deviation 2.374
|
25.35 mmHg
Standard Deviation 2.666
|
25.99 mmHg
Standard Deviation 2.828
|
|
Intraocular Pressure (IOP)
Day 29, Diurnal Mean
|
17.33 mmHg
Standard Deviation 2.770
|
16.52 mmHg
Standard Deviation 2.992
|
19.13 mmHg
Standard Deviation 3.219
|
18.44 mmHg
Standard Deviation 2.565
|
Adverse Events
PG324 Ophthalmic Solution 0.01%
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
PG324 Ophthalmic Solution 0.02%
Serious events: 0 serious events
Other events: 55 other events
Deaths: 0 deaths
Netarsudil (AR-13324) Ophthalmic Solution
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Latanoprost Ophthalmic Solution
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PG324 Ophthalmic Solution 0.01%
n=73 participants at risk；n=74 participants at risk
PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
PG324 Ophthalmic Solution 0.02%
n=73 participants at risk
PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
Netarsudil (AR-13324) Ophthalmic Solution
n=78 participants at risk
Netarsudil (AR-13324) Ophthalmic Solution
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
Latanoprost Ophthalmic Solution
n=73 participants at risk
Latanoprost Ophthalmic Solution
Latanoprost Ophthalmic Solution: 1 drop daily (evening)
|
|---|---|---|---|---|
|
Eye disorders
Ulcerative Keratitis
|
0.00%
0/74 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
0.00%
0/73 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
0.00%
0/78 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
1.4%
1/73 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/74 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
0.00%
0/73 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
0.00%
0/78 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
1.4%
1/73 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/74 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
0.00%
0/73 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
0.00%
0/78 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
1.4%
1/73 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/74 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
0.00%
0/73 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
0.00%
0/78 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
1.4%
1/73 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
Other adverse events
| Measure |
PG324 Ophthalmic Solution 0.01%
n=73 participants at risk；n=74 participants at risk
PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
PG324 Ophthalmic Solution 0.02%
n=73 participants at risk
PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
Netarsudil (AR-13324) Ophthalmic Solution
n=78 participants at risk
Netarsudil (AR-13324) Ophthalmic Solution
1 drop in the evening (PM), once daily (QD), both eyes (OU)
|
Latanoprost Ophthalmic Solution
n=73 participants at risk
Latanoprost Ophthalmic Solution
Latanoprost Ophthalmic Solution: 1 drop daily (evening)
|
|---|---|---|---|---|
|
Eye disorders
Conjunctival Hyperaemia
|
39.7%
29/73 • Number of events 29 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
39.7%
29/73 • Number of events 29 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
34.6%
27/78 • Number of events 27 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
12.3%
9/73 • Number of events 9 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
|
Eye disorders
Lacrimation Increased
|
1.4%
1/73 • Number of events 1 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
5.5%
4/73 • Number of events 4 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
1.3%
1/78 • Number of events 1 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
0.00%
0/73 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
|
General disorders
Instillation Site Erythema
|
15.1%
11/73 • Number of events 11 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
19.2%
14/73 • Number of events 14 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
21.8%
17/78 • Number of events 17 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
1.4%
1/73 • Number of events 1 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
|
General disorders
Instillation Site Pain
|
6.8%
5/73 • Number of events 5 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
11.0%
8/73 • Number of events 8 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
5.1%
4/78 • Number of events 4 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
2.7%
2/73 • Number of events 2 • Adverse Event Data was collected over the course of the study of the 28 day treatment period
1 Subject is not considered in the safety population; this subject was randomized but not treated. ( Number of subjects applies to All cause mortality, SAEs and other AEs sections)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place