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Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT02057575
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Open Angle Glaucoma
Ocular Hypertension
Interventions Drug: PG324 Ophthalmic Solution 0.01%
Drug: PG324 Ophthalmic Solution 0.02%
Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Drug: Latanoprost Ophthalmic Solution 0.005%
Enrollment 298
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PG324 Ophthalmic Solution 0.01% PG324 Ophthalmic Solution 0.02% Netarsudil (AR-13324) Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Hide Arm/Group Description

PG324 Ophthalmic Solution 0.01%

1 drop in the evening (PM), once daily (QD), both eyes (OU)

PG324 Ophthalmic Solution 0.02%

1 drop in the evening (PM), once daily (QD), both eyes (OU)

Netarsudil (AR-13324) Ophthalmic Solution 0.02%

1 drop in the evening (PM), once daily (QD), both eyes (OU)

Latanoprost Ophthalmic Solution 0.005%

1 drop in the evening (PM), once daily (QD), both eyes (OU)

Period Title: Overall Study
Started 74 73 78 73
Completed 73 69 78 72
Not Completed 1 4 0 1
Reason Not Completed
Adverse Event             0             2             0             1
Withdrawal by Subject             1             0             0             0
Dissallowed Concurrent Medication             0             1             0             0
Protocol Violation             0             1             0             0
Arm/Group Title PG324 Ophthalmic Solution 0.01% PG324 Ophthalmic Solution 0.02% Netarsudil (AR-13324) Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005% Total
Hide Arm/Group Description

PG324 Ophthalmic Solution 0.01%

1 drop in the evening (PM), once daily (QD), both eyes (OU)

PG324 Ophthalmic Solution 0.02%

1 drop in the evening (PM), once daily (QD), both eyes (OU)

Netarsudil (AR-13324) Ophthalmic Solution 0.02%

1 drop in the evening (PM), once daily (QD), both eyes (OU)

Latanoprost Ophthalmic Solution 0.005%

1 drop daily in the evening (PM), once daily (QD), both eyes (OU)

Total of all reporting groups
Overall Number of Baseline Participants 74 73 78 73 298
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 73 participants 78 participants 73 participants 298 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
  39.2%
35
  47.9%
33
  42.3%
28
  38.4%
125
  41.9%
>=65 years
45
  60.8%
38
  52.1%
45
  57.7%
45
  61.6%
173
  58.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 73 participants 78 participants 73 participants 298 participants
65.4  (11.26) 64.2  (11.07) 64.8  (11.28) 65.1  (12.80) 64.9  (11.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 73 participants 78 participants 73 participants 298 participants
Female
47
  63.5%
39
  53.4%
43
  55.1%
46
  63.0%
175
  58.7%
Male
27
  36.5%
34
  46.6%
35
  44.9%
27
  37.0%
123
  41.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 73 participants 78 participants 73 participants 298 participants
Hispanic or Latino
15
  20.3%
20
  27.4%
15
  19.2%
14
  19.2%
64
  21.5%
Not Hispanic or Latino
59
  79.7%
53
  72.6%
63
  80.8%
59
  80.8%
234
  78.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 73 participants 78 participants 73 participants 298 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   1.3%
0
   0.0%
1
   0.3%
Asian
3
   4.1%
1
   1.4%
2
   2.6%
1
   1.4%
7
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  20.3%
10
  13.7%
17
  21.8%
12
  16.4%
54
  18.1%
White
56
  75.7%
62
  84.9%
58
  74.4%
60
  82.2%
236
  79.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Intraocular Pressure (IOP)
Hide Description The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.
Time Frame Study treatment was administered for 28 days, and outcome measures collected on Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (mITT) population
Arm/Group Title PG324 Ophthalmic Solution 0.01% PG324 Ophthalmic Solution 0.02% Netarsudil (AR-13324) Ophthalmic Solution Latanoprost Ophthalmic Solution
Hide Arm/Group Description:

PG324 Ophthalmic Solution 0.01%

1 drop in the evening (PM), once daily (QD), both eyes (OU)

PG324 Ophthalmic Solution 0.02%

1 drop in the evening (PM), once daily (QD), both eyes (OU)

Netarsudil (AR-13324) Ophthalmic Solution

1 drop in the evening (PM), once daily (QD), both eyes (OU)

Latanoprost Ophthalmic Solution

1 drop in the evening (PM), once daily (QD), both eyes (OU)

Overall Number of Participants Analyzed 73 72 78 73
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 1, Diurnal Mean 25.11  (2.330) 25.12  (2.374) 25.35  (2.666) 25.99  (2.828)
Day 29, Diurnal Mean 17.33  (2.770) 16.52  (2.992) 19.13  (3.219) 18.44  (2.565)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PG324 Ophthalmic Solution 0.01%, Netarsudil (AR-13324) Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments PG324 0.01% vs netarsudil
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PG324 Ophthalmic Solution 0.02%, Netarsudil (AR-13324) Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments PG324 0.02% vs. netarsudil
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PG324 Ophthalmic Solution 0.01%, Latanoprost Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments PG324 0.01% vs. latanoprost
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PG324 Ophthalmic Solution 0.02%, Latanoprost Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments PG324 0.02% vs. latanoprost
Time Frame Adverse Event Data was collected over the course of the study of the 28 day treatment period
Adverse Event Reporting Description 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)
 
Arm/Group Title PG324 Ophthalmic Solution 0.01% PG324 Ophthalmic Solution 0.02% Netarsudil (AR-13324) Ophthalmic Solution Latanoprost Ophthalmic Solution
Hide Arm/Group Description

PG324 Ophthalmic Solution 0.01%

1 drop in the evening (PM), once daily (QD), both eyes (OU)

PG324 Ophthalmic Solution 0.02%

1 drop in the evening (PM), once daily (QD), both eyes (OU)

Netarsudil (AR-13324) Ophthalmic Solution

1 drop in the evening (PM), once daily (QD), both eyes (OU)

Latanoprost Ophthalmic Solution

Latanoprost Ophthalmic Solution: 1 drop daily (evening)

All-Cause Mortality
PG324 Ophthalmic Solution 0.01% PG324 Ophthalmic Solution 0.02% Netarsudil (AR-13324) Ophthalmic Solution Latanoprost Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)      0/73 (0.00%)      0/78 (0.00%)      0/73 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
PG324 Ophthalmic Solution 0.01% PG324 Ophthalmic Solution 0.02% Netarsudil (AR-13324) Ophthalmic Solution Latanoprost Ophthalmic Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/74 (0.00%)      0/73 (0.00%)      0/78 (0.00%)      3/73 (4.11%)    
Eye disorders         
Ulcerative Keratitis  1  0/74 (0.00%)  0/73 (0.00%)  0/78 (0.00%)  1/73 (1.37%) 
Gastrointestinal disorders         
Large Intestine Perforation  1  0/74 (0.00%)  0/73 (0.00%)  0/78 (0.00%)  1/73 (1.37%) 
Hepatobiliary disorders         
Cholecystitis Acute  1  0/74 (0.00%)  0/73 (0.00%)  0/78 (0.00%)  1/73 (1.37%) 
Infections and infestations         
Diverticulitis  1  0/74 (0.00%)  0/73 (0.00%)  0/78 (0.00%)  1/73 (1.37%) 
1
Term from vocabulary, MedDRA (15.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PG324 Ophthalmic Solution 0.01% PG324 Ophthalmic Solution 0.02% Netarsudil (AR-13324) Ophthalmic Solution Latanoprost Ophthalmic Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/73 (63.01%)      55/73 (75.34%)      49/78 (62.82%)      12/73 (16.44%)    
Eye disorders         
Conjunctival Hyperaemia  1  29/73 (39.73%)  29 29/73 (39.73%)  29 27/78 (34.62%)  27 9/73 (12.33%)  9
Lacrimation Increased  1  1/73 (1.37%)  1 4/73 (5.48%)  4 1/78 (1.28%)  1 0/73 (0.00%)  0
General disorders         
Instillation Site Erythema  1  11/73 (15.07%)  11 14/73 (19.18%)  14 17/78 (21.79%)  17 1/73 (1.37%)  1
Instillation Site Pain  1  5/73 (6.85%)  5 8/73 (10.96%)  8 4/78 (5.13%)  4 2/73 (2.74%)  2
1
Term from vocabulary, MedDRA (15.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Theresa GH Heah, MD, MBA
Organization: Aerie Pharmaceuticals, Inc
Phone: 908-947-3844
EMail: theah@aeriepharma.com
Layout table for additonal information
Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02057575     History of Changes
Other Study ID Numbers: PG324-CS201
First Submitted: February 6, 2014
First Posted: February 7, 2014
Results First Submitted: March 27, 2019
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019