Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects 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: NCT02558374
Recruitment Status : Completed
First Posted : September 24, 2015
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Open-angle Glaucoma
Ocular Hypertension
Interventions Drug: AR-13324 Ophthalmic Solution 0.02%
Drug: Timolol Maleate Ophthalmic Solution 0.5% BID
Other: Placebo
Enrollment 708
Recruitment Details Participants were recruited at 53 sites starting in September 2015
Pre-assignment Details  
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID
Hide Arm/Group Description 1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU) 1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
Period Title: Overall Study
Started 351 357
Completed 243 314
Not Completed 108 43
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID Total
Hide Arm/Group Description 1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU) 1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) Total of all reporting groups
Overall Number of Baseline Participants 351 357 708
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 351 participants 357 participants 708 participants
64.1  (11.55) 64.5  (10.97) 64.3  (11.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 351 participants 357 participants 708 participants
Female
208
  59.3%
237
  66.4%
445
  62.9%
Male
143
  40.7%
120
  33.6%
263
  37.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 351 participants 357 participants 708 participants
Hispanic or Latino
89
  25.4%
87
  24.4%
176
  24.9%
Not Hispanic or Latino
262
  74.6%
270
  75.6%
532
  75.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 351 participants 357 participants 708 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
7
   2.0%
6
   1.7%
13
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.3%
1
   0.1%
Black or African American
84
  23.9%
75
  21.0%
159
  22.5%
White
259
  73.8%
274
  76.8%
533
  75.3%
More than one race
0
   0.0%
1
   0.3%
1
   0.1%
Unknown or Not Reported
1
   0.3%
0
   0.0%
1
   0.1%
1.Primary Outcome
Title IOP (Intraocular Pressure)
Hide Description The primary efficacy outcome is mean IOP
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID
Hide Arm/Group Description:
1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
Overall Number of Participants Analyzed 306 316
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 1, 0800 hours 23.93  (2.441) 23.89  (2.318)
Day 1, 1000 hours 22.67  (2.826) 22.77  (2.565)
Day 1, 1600 hours 22.17  (2.857) 22.04  (2.708)
Day 15, 0800 hours 19.20  (3.833) 18.60  (3.396)
Day 15, 1000 hours 17.93  (3.678) 17.80  (3.237)
Day 15, 1600 hours 17.76  (3.527) 17.85  (3.102)
Day 43, 0800 hours 19.45  (3.929) 18.52  (3.316)
Day 43, 1000 hours 18.12  (3.560) 17.89  (3.157)
Day 43, 1600 hours 17.89  (3.438) 17.88  (3.356)
Day 90, 0800 hours 19.24  (3.889) 18.35  (3.196)
Day 90, 1000 hours 18.30  (3.637) 17.60  (3.173)
Day 90, 1600 hours 18.02  (3.644) 17.66  (3.080)
2.Secondary Outcome
Title Extent of Exposure
Hide Description Exposure to study medication in days for all treatment groups
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID
Hide Arm/Group Description:
1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
Overall Number of Participants Analyzed 351 357
Mean (Standard Deviation)
Unit of Measure: days
147.4  (54.47) 167.7  (36.40)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID
Hide Arm/Group Description 1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU) 1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
All-Cause Mortality
AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID
Affected / at Risk (%) Affected / at Risk (%)
Total   1/351 (0.28%)   0/357 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID
Affected / at Risk (%) Affected / at Risk (%)
Total   8/351 (2.28%)   10/357 (2.80%) 
Cardiac disorders     
Atrial Fibrillation  1  0/351 (0.00%)  1/357 (0.28%) 
Cardiac Arrest  1  1/351 (0.28%)  0/357 (0.00%) 
Cardiomegaly  1  0/351 (0.00%)  1/357 (0.28%) 
Coronary Artery Disease  1  0/351 (0.00%)  1/357 (0.28%) 
Myocardial Infarction  1  1/351 (0.28%)  0/357 (0.00%) 
Gastrointestinal disorders     
Abdominal Discomfort  1  0/351 (0.00%)  1/357 (0.28%) 
Gastric Volvulus  1  1/351 (0.28%)  0/357 (0.00%) 
Hiatus Hernia  1  1/351 (0.28%)  0/357 (0.00%) 
Infections and infestations     
Pneumonia  1  0/351 (0.00%)  1/357 (0.28%) 
Injury, poisoning and procedural complications     
Fall  1  0/351 (0.00%)  1/357 (0.28%) 
Radius Fracture  1  0/351 (0.00%)  1/357 (0.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder Cancer Recurrent  1  1/351 (0.28%)  0/357 (0.00%) 
Chronic Myeloid Leukaemia  1  1/351 (0.28%)  0/357 (0.00%) 
Invasive Ductal Breast Carcinoma  1  0/351 (0.00%)  1/357 (0.28%) 
Papillary Thyroid Cancer  1  1/351 (0.28%)  0/357 (0.00%) 
Uterine Leiomyoma  1  0/351 (0.00%)  1/357 (0.28%) 
Nervous system disorders     
Transient Ischaemic Attack  1  1/351 (0.28%)  1/357 (0.28%) 
Facial Paralysis  1  0/351 (0.00%)  1/357 (0.28%) 
Psychiatric disorders     
Mental Status Changes  1  0/351 (0.00%)  1/357 (0.28%) 
Renal and urinary disorders     
Bladder Prolapse  1  1/351 (0.28%)  0/357 (0.00%) 
Reproductive system and breast disorders     
Cervical Dysplasia  1  1/351 (0.28%)  0/357 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia Aspiration  1  1/351 (0.28%)  0/357 (0.00%) 
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%
AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID
Affected / at Risk (%) Affected / at Risk (%)
Total   245/351 (69.80%)   139/357 (38.94%) 
Eye disorders     
Conjunctival Hyperaemia  1  168/351 (47.86%)  33/357 (9.24%) 
Cornea Verticillata  1  86/351 (24.50%)  0/357 (0.00%) 
Conjunctival Haemorrhage  1  56/351 (15.95%)  11/357 (3.08%) 
Lacrimation Increased  1  26/351 (7.41%)  5/357 (1.40%) 
Erythema of Eyelid  1  26/351 (7.41%)  2/357 (0.56%) 
Vision Blurred  1  22/351 (6.27%)  4/357 (1.12%) 
General disorders     
Instillation Site Pain  1  83/351 (23.65%)  92/357 (25.77%) 
Instillation Site Erythema  1  36/351 (10.26%)  4/357 (1.12%) 
Investigations     
Vital Dye Staining Cornea Present  1  34/351 (9.69%)  24/357 (6.72%) 
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: Nancy Ramirez-Davis, Director of Clinical Project Management
Organization: Aerie Pharmaceuticals, Inc.
Phone: 908-947-3543
Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02558374     History of Changes
Other Study ID Numbers: AR-13324-CS304
First Submitted: September 16, 2015
First Posted: September 24, 2015
Results First Submitted: January 17, 2018
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018