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Trial record 17 of 19 for:    netarsudil

Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02674854
Recruitment Status : Completed
First Posted : February 5, 2016
Results First Posted : May 1, 2019
Last Update Posted : May 21, 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 0.02%/0.005%
Drug: Netarsudil (AR-13324) ophthalmic solution 0.02%
Drug: Latanoprost ophthalmic solution 0.005%
Enrollment 750
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PG324 Ophthalmic Solution 0.02%/0.005% Netarsudil (AR-13324) Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Hide Arm/Group Description 1 drop daily in the evening (PM) in both eyes (OU) 1 drop daily in the evening (PM) in both eyes (OU) 1 drop daily in the evening (PM) in both eyes (OU)
Period Title: Overall Study
Started 245 255 250
Completed 221 228 236
Not Completed 24 27 14
Reason Not Completed
Adverse Event             17             15             5
Withdrawal by Subject             1             5             4
No-compliant subject             1             0             1
Lost to Follow-up             1             0             2
Lack of Efficacy             0             3             0
Disallowed Concurrent Medication             2             2             0
Protocol Violation             1             1             2
Death             0             1             0
Subject missed V6.2             1             0             0
Arm/Group Title PG324 Ophthalmic Solution Netarsudil (AR-13324) Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005% Total
Hide Arm/Group Description 1 drop daily in the evening (PM) in both eyes (OU) 1 drop daily in the evening (PM) in both eyes (OU) 1 drop daily in the evening (PM) in both eyes (OU) Total of all reporting groups
Overall Number of Baseline Participants 245 255 250 750
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 255 participants 250 participants 750 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
118
  48.2%
109
  42.7%
112
  44.8%
339
  45.2%
>=65 years
127
  51.8%
146
  57.3%
138
  55.2%
411
  54.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 245 participants 255 participants 250 participants 750 participants
64.2  (11.81) 64.5  (10.58) 64.3  (11.41) 64.3  (11.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 255 participants 250 participants 750 participants
Female
152
  62.0%
153
  60.0%
144
  57.6%
449
  59.9%
Male
93
  38.0%
102
  40.0%
106
  42.4%
301
  40.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 255 participants 250 participants 750 participants
Hispanic or Latino
45
  18.4%
48
  18.8%
55
  22.0%
148
  19.7%
Not Hispanic or Latino
200
  81.6%
207
  81.2%
195
  78.0%
602
  80.3%
Unknown or Not Reported
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 245 participants 255 participants 250 participants 750 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   0.4%
1
   0.1%
Asian
7
   2.9%
11
   4.3%
6
   2.4%
24
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
74
  30.2%
76
  29.8%
79
  31.6%
229
  30.5%
White
161
  65.7%
165
  64.7%
163
  65.2%
489
  65.2%
More than one race
2
   0.8%
3
   1.2%
0
   0.0%
5
   0.7%
Unknown or Not Reported
1
   0.4%
0
   0.0%
1
   0.4%
2
   0.3%
1.Primary Outcome
Title Intraocular Pressure (IOP)
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population with Monte Carlo Markov Chain (MCMC) imputation
Arm/Group Title PG324 Ophthalmic Solution Netarsudil (AR-13324) Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Hide Arm/Group Description:
1 drop daily in the evening (PM) in both eyes (OU)
1 drop daily in the evening (PM) in both eyes (OU)
1 drop daily in the evening (PM) in both eyes (OU)
Overall Number of Participants Analyzed 245 255 250
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 1, 0800 hours 24.69  (3.422) 24.66  (3.148) 24.75  (3.240)
Day 1, 1000 hours 23.33  (3.399) 23.40  (3.538) 23.23  (3.339)
Day 1, 1600 hours 22.37  (3.492) 22.76  (3.558) 22.59  (3.451)
Day 15, 0800 hours 16.06  (3.370) 19.35  (4.279) 18.10  (3.375)
Day 15, 1000 hours 15.31  (3.272) 17.99  (3.909) 17.61  (3.264)
Day 15, 1600 hours 15.16  (3.032) 17.53  (3.772) 17.08  (3.283)
Day 43, 0800 hours 16.43  (3.717) 19.52  (4.273) 17.93  (3.586)
Day 43, 1000 hours 15.54  (3.533) 18.40  (3.810) 17.35  (3.224)
Day 43, 1600 hours 15.45  (3.525) 17.95  (3.776) 17.09  (3.271)
Day 90, 0800 hours 16.45  (3.572) 19.72  (4.419) 17.98  (3.400)
Day 90, 1000 hours 15.58  (3.307) 18.30  (3.846) 17.48  (3.366)
Day 90, 1600 hours 15.52  (3.210) 17.94  (3.627) 17.14  (3.044)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PG324 Ophthalmic Solution, Netarsudil (AR-13324) Ophthalmic Solution 0.02%
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 vs. netarsudil
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PG324 Ophthalmic Solution, Latanoprost Ophthalmic Solution 0.005%
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 vs. latanoprost
Time Frame Adverse event data was collected during the 90 day treatment period.
Adverse Event Reporting Description 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
 
Arm/Group Title PG324 Ophthalmic Solution Netarsudil (AR-13324) Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Hide Arm/Group Description 1 drop daily in the evening (PM) in both eyes (OU) 1 drop daily in the evening (PM) in both eyes (OU) 1 drop daily in the evening (PM) in both eyes (OU)
All-Cause Mortality
PG324 Ophthalmic Solution Netarsudil (AR-13324) Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/244 (0.00%)      1/255 (0.39%)      0/251 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
PG324 Ophthalmic Solution Netarsudil (AR-13324) Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/244 (0.82%)      6/255 (2.35%)      5/251 (1.99%)    
Cardiac disorders       
Atrial Fibrillation  1  1/244 (0.41%)  1 2/255 (0.78%)  2 0/251 (0.00%)  0
Cardiac Failure Congestive  1  0/244 (0.00%)  0 1/255 (0.39%)  1 1/251 (0.40%)  1
Cardiac Arrest  1  0/244 (0.00%)  0 1/255 (0.39%)  1 0/251 (0.00%)  0
Coronary Artery Disease  1  1/244 (0.41%)  1 0/255 (0.00%)  0 0/251 (0.00%)  0
Eye disorders       
Retinal Detachment  1  0/244 (0.00%)  0 0/255 (0.00%)  0 1/251 (0.40%)  1
Hepatobiliary disorders       
Cholecystitis Acute  1  0/244 (0.00%)  0 0/255 (0.00%)  0 1/251 (0.40%)  1
Infections and infestations       
Bronchitis  1  0/244 (0.00%)  0 1/255 (0.39%)  1 0/251 (0.00%)  0
Device Related Infection  1  0/244 (0.00%)  0 0/255 (0.00%)  0 1/251 (0.40%)  1
Pneumonia  1  0/244 (0.00%)  0 0/255 (0.00%)  0 1/251 (0.40%)  1
Nervous system disorders       
Vertebral Artery Stenosis  1  0/244 (0.00%)  0 1/255 (0.39%)  1 0/251 (0.00%)  0
Psychiatric disorders       
Mental Status Changes  1  1/244 (0.41%)  1 0/255 (0.00%)  0 0/251 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pulmonary Embolism  1  0/244 (0.00%)  0 1/255 (0.39%)  1 0/251 (0.00%)  0
1
Term from vocabulary, MedDRA (19.0)
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 Netarsudil (AR-13324) Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   157/244 (64.34%)      143/255 (56.08%)      78/251 (31.08%)    
Eye disorders       
Conjunctival Hyperaemia  1  126/244 (51.64%)  126 102/255 (40.00%)  102 51/251 (20.32%)  51
Cornea Verticillata  1  32/244 (13.11%)  32 25/255 (9.80%)  25 0/251 (0.00%)  0
Conjunctival Haemorrhage  1  14/244 (5.74%)  14 17/255 (6.67%)  17 2/251 (0.80%)  2
Corneal Disorder  1  14/244 (5.74%)  14 12/255 (4.71%)  12 0/251 (0.00%)  0
General disorders       
Instillation Site Pain  1  42/244 (17.21%)  42 23/255 (9.02%)  23 15/251 (5.98%)  15
Instillation Site Discomfort  1  15/244 (6.15%)  15 16/255 (6.27%)  16 2/251 (0.80%)  2
Investigations       
Vital Dye Staining Cornea Present  1  8/244 (3.28%)  8 13/255 (5.10%)  13 10/251 (3.98%)  10
1
Term from vocabulary, MedDRA (19.0)
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
Name/Title: Theresa GH Heah, MD, MBA
Organization: Aerie Pharmaceuticals, Inc
Phone: 908-947-3844
Publications of Results:
Walter TR, Ahmed IK et al. Ophthalmology glaucoma, 2019, pg. 1-10 https://doi.org/10.1016/j.ogla.2019.03.007
Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02674854     History of Changes
Other Study ID Numbers: PG324-CS302
First Submitted: February 1, 2016
First Posted: February 5, 2016
Results First Submitted: April 11, 2019
Results First Posted: May 1, 2019
Last Update Posted: May 21, 2019