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Trial record 20 of 22 for:    netarsudil

Double-masked Study of PG324 Ophthalmic Solution in Patients With 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: NCT02558400
Recruitment Status : Completed
First Posted : September 24, 2015
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 0.02%/0.005%
Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Drug: Latanoprost Ophthalmic Solution 0.005%
Enrollment 718
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PG324 Ophthalmic Solution 0.02%/0.005% AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Hide Arm/Group Description PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
Period Title: Overall Study
Started 238 244 236
Completed 159 148 203
Not Completed 79 96 33
Reason Not Completed
Adverse Event             47             53             4
Withdrawal by Subject             13             9             8
Non-Compliant             0             1             3
Lost to Follow-up             5             5             4
Lack of Efficacy             0             13             1
Disallowed Concurrent Medication             6             7             5
Physician Decision             2             2             0
Protocol Violation             6             3             8
Death             0             1             0
Ineligible for the study             0             2             0
Arm/Group Title PG324 Ophthalmic Solution AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005% Total
Hide Arm/Group Description PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) Total of all reporting groups
Overall Number of Baseline Participants 238 244 236 718
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 238 participants 244 participants 236 participants 718 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
109
  45.8%
107
  43.9%
95
  40.3%
311
  43.3%
>=65 years
129
  54.2%
137
  56.1%
141
  59.7%
407
  56.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 238 participants 244 participants 236 participants 718 participants
64.4  (11.33) 64.6  (10.97) 65.4  (10.98) 64.8  (11.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 238 participants 244 participants 236 participants 718 participants
Female
134
  56.3%
136
  55.7%
136
  57.6%
406
  56.5%
Male
104
  43.7%
108
  44.3%
100
  42.4%
312
  43.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 238 participants 244 participants 236 participants 718 participants
Hispanic or Latino
30
  12.6%
32
  13.1%
30
  12.7%
92
  12.8%
Not Hispanic or Latino
208
  87.4%
212
  86.9%
206
  87.3%
626
  87.2%
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 238 participants 244 participants 236 participants 718 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
7
   2.9%
6
   2.5%
10
   4.2%
23
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
69
  29.0%
70
  28.7%
67
  28.4%
206
  28.7%
White
162
  68.1%
167
  68.4%
157
  66.5%
486
  67.7%
More than one race
0
   0.0%
1
   0.4%
2
   0.8%
3
   0.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Intraocular Pressure (IOP)
Hide Description The primary efficacy variable was mean IOP at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry. Secondary analysis were conducted as a part of safety measurements to month 12 on treatment.
Time Frame Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population
Arm/Group Title PG324 Ophthalmic Solution AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Hide Arm/Group Description:
PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
Overall Number of Participants Analyzed 238 244 236
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 1, 0800 hours 24.84  (3.316) 24.81  (3.335) 24.59  (2.914)
Day 1, 1000 hours 23.72  (3.587) 23.45  (3.510) 23.43  (3.385)
Day 1, 1600 hours 22.59  (3.610) 22.63  (3.674) 23.43  (3.370)
Day 15, 0800 hours 15.68  (3.532) 18.66  (4.189) 17.74  (3.467)
Day 15, 1000 hours 14.93  (3.417) 17.78  (4.219) 17.36  (3.548)
Day 15, 1600 hours 14.83  (2.978) 17.25  (3.814) 17.11  (3.236)
Day 43, 0800 hours 16.04  (3.268) 19.06  (4.593) 17.58  (3.465)
Day 43, 1000 hours 15.39  (3.175) 17.92  (4.168) 17.06  (3.250)
Day 43, 1600 hours 15.43  (3.065) 17.54  (3.855) 16.97  (3.240)
Day 90, 0800 hours 16.37  (3.377) 19.04  (4.537) 17.53  (3.280)
Day 90, 1000 hours 15.41  (3.038) 17.96  (4.262) 16.88  (3.139)
Day 90, 1600 hours 15.49  (3.126) 17.30  (3.769) 16.67  (3.115)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PG324 Ophthalmic Solution, AR-13324 Ophthalmic Solution 0.02%
Comments [Not Specified]
Type of Statistical Test Superiority
Comments To claim superiority PG324 had to be statistically superior to netarsudil and to latanoprost at all 9 of 9 primary efficacy timepoints
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
2.Secondary Outcome
Title Extent of Exposure
Hide Description Exposure to study medication in days for all treatment groups
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population= all randomized subjects who received at least 1 dose of study medication. The safety population summarized subjects as-treated. 1 Subject was randomized to netarsudil but received latanoprost. Therefore, 1 less subject is in the netarsudil group and 1 additional subject is in the latanoprost group for the safety population.
Arm/Group Title PG324 Ophthalmic Solution 0.02%/0.005% AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Hide Arm/Group Description:

Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution

PG324 Ophthalmic Solution 0.02%/0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)

Netarsudil 0.02% ophthalmic solution

Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)

Latanoprost 0.005% ophthalmic solution

Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)

Overall Number of Participants Analyzed 238 243 237
Mean (Standard Deviation)
Unit of Measure: days
275.7  (129.94) 266.2  (131.60) 330.4  (89.60)
Time Frame Adverse event data was collected during the course of the study of 12 month treatment and 2 month safety follow up.The safety population summarized subjects as-treated.
Adverse Event Reporting Description Safety population, defined as all randomized subjects who received at least 1 dose of investigational product.The safety population summarized subjects as-treated. 1 Subject was randomized to netarsudil but received latanoprost. Therefore, 1 less subject is in the netarsudil group and 1 additional subject is in the latanoprost group for the safety population. (applies to the numbers of subjects for SAEs, all cause mortality and other AEs sections)
 
Arm/Group Title PG324 Ophthalmic Solution AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Hide Arm/Group Description PG324 Ophthalmic Solution: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) Netarsudil (AR-13324) Ophthalmic Solution 0.02%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU) Latanoprost Ophthalmic Solution 0.005%: 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
All-Cause Mortality
PG324 Ophthalmic Solution AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/238 (0.00%)      1/243 (0.41%)      0/237 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
PG324 Ophthalmic Solution AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/238 (2.10%)      10/243 (4.12%)      10/237 (4.22%)    
Blood and lymphatic system disorders       
Anaemia  1  1/238 (0.42%)  1 0/243 (0.00%)  0 0/237 (0.00%)  0
Cardiac disorders       
Myocardial Infarction  1  0/238 (0.00%)  0 0/243 (0.00%)  0 2/237 (0.84%)  2
Coronary Artery Stenosis  1  0/238 (0.00%)  0 1/243 (0.41%)  1 0/237 (0.00%)  0
Gastrointestinal disorders       
Abdominal Pain  1  1/238 (0.42%)  1 0/243 (0.00%)  0 0/237 (0.00%)  0
Gastrointestinal Haemorrhage  1  0/238 (0.00%)  0 1/243 (0.41%)  1 0/237 (0.00%)  0
Impaired Gastric Emptying  1  0/238 (0.00%)  0 1/243 (0.41%)  1 0/237 (0.00%)  0
Lower Gastrointestinal Haemorrhage  1  0/238 (0.00%)  0 0/243 (0.00%)  0 1/237 (0.42%)  1
Hepatobiliary disorders       
Cholecystitis  1  1/238 (0.42%)  1 0/243 (0.00%)  0 0/237 (0.00%)  0
Infections and infestations       
Cellulitis  1  0/238 (0.00%)  0 1/243 (0.41%)  1 0/237 (0.00%)  0
Pneumonia  1  1/238 (0.42%)  1 0/243 (0.00%)  0 0/237 (0.00%)  0
Sepsis  1  0/238 (0.00%)  0 0/243 (0.00%)  0 1/237 (0.42%)  1
Injury, poisoning and procedural complications       
Fall  1  0/238 (0.00%)  0 0/243 (0.00%)  0 1/237 (0.42%)  1
Femoral Neck Fracture  1  0/238 (0.00%)  0 0/243 (0.00%)  0 1/237 (0.42%)  1
Metabolism and nutrition disorders       
Hypoglycaemia  1  0/238 (0.00%)  0 1/243 (0.41%)  1 0/237 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Osteoarthritis  1  0/238 (0.00%)  0 0/243 (0.00%)  0 1/237 (0.42%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder Cancer  1  0/238 (0.00%)  0 1/243 (0.41%)  1 0/237 (0.00%)  0
Breast Cancer  1  1/238 (0.42%)  1 0/243 (0.00%)  0 0/237 (0.00%)  0
Gastric Cancer Recurrent  1  0/238 (0.00%)  0 0/243 (0.00%)  0 1/237 (0.42%)  1
Intraductal Proliferative Breast Lesion  1  0/238 (0.00%)  0 1/243 (0.41%)  1 0/237 (0.00%)  0
Ovarian Adenoma  1  0/238 (0.00%)  0 0/243 (0.00%)  0 1/237 (0.42%)  1
Prostate Cancer Recurrent  1  0/238 (0.00%)  0 0/243 (0.00%)  0 1/237 (0.42%)  1
Nervous system disorders       
Carotid Artery Stenosis  1  1/238 (0.42%)  1 0/243 (0.00%)  0 0/237 (0.00%)  0
Metabolic Encephalopathy  1  0/238 (0.00%)  0 0/243 (0.00%)  0 1/237 (0.42%)  1
Syncope  1  0/238 (0.00%)  0 0/243 (0.00%)  0 1/237 (0.42%)  1
Pregnancy, puerperium and perinatal conditions       
Abortion Spontaneous  1  0/238 (0.00%)  0 1/243 (0.41%)  1 0/237 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Bronchitis Chronic  1  0/238 (0.00%)  0 1/243 (0.41%)  1 0/237 (0.00%)  0
Pulmonary Embolism  1  0/238 (0.00%)  0 0/243 (0.00%)  0 1/237 (0.42%)  1
Vascular disorders       
Arteriosclerosis  1  0/238 (0.00%)  0 1/243 (0.41%)  1 0/237 (0.00%)  0
Deep Vein Thrombosis  1  0/238 (0.00%)  0 0/243 (0.00%)  0 1/237 (0.42%)  1
Hypertension  1  0/238 (0.00%)  0 1/243 (0.41%)  1 0/237 (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 AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   169/238 (71.01%)      160/243 (65.84%)      74/237 (31.22%)    
Eye disorders       
Conjunctival Hyperaemia  1  133/238 (55.88%)  133 115/243 (47.33%)  115 44/237 (18.57%)  44
Cornea Verticillata  1  39/238 (16.39%)  39 32/243 (13.17%)  32 0/237 (0.00%)  0
Eye Pruritus  1  20/238 (8.40%)  20 20/243 (8.23%)  20 2/237 (0.84%)  2
Lacrimation Increased  1  15/238 (6.30%)  15 17/243 (7.00%)  17 1/237 (0.42%)  1
Conjunctival Haemorrhage  1  10/238 (4.20%)  10 14/243 (5.76%)  14 2/237 (0.84%)  2
Punctate Keratitis  1  9/238 (3.78%)  9 13/243 (5.35%)  13 4/237 (1.69%)  4
Vision Blurred  1  9/238 (3.78%)  9 14/243 (5.76%)  14 3/237 (1.27%)  3
General disorders       
Instillation Site Pain  1  52/238 (21.85%)  52 55/243 (22.63%)  55 18/237 (7.59%)  18
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
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: NCT02558400     History of Changes
Other Study ID Numbers: PG324-CS301
First Submitted: September 16, 2015
First Posted: September 24, 2015
Results First Submitted: April 11, 2019
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019