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Trial record 9 of 22 for:    netarsudil

Evaluation of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma and 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: NCT02207621
Recruitment Status : Completed
First Posted : August 4, 2014
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 Ocular Hypertension
Open-angle Glaucoma
Interventions Drug: AR-13324 Ophthalmic Solution 0.02%
Drug: Timolol maleate Ophthalmic Solution 0.5% BID
Other: Placebo
Drug: AR-13324 Ophthalmic Solution 0.02% BID
Enrollment 756
Recruitment Details 62 clinical trial sites participated in this study, of which 60 clinical trial sites enrolled participants. Screening started in June 2014. Enrollment started in July 2014. The last participant was enrolled in March 2015.
Pre-assignment Details Prior to enrollment, adult participants were required to have a Screening Visit and 2 Qualification Visits to allow for washout of ocular hypotensive medication.
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID AR-13324 Ophthalmic Solution 0.02% BID
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 Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) 1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
Period Title: Overall Study
Started 251 251 254
Completed 146 204 86
Not Completed 105 47 168
Reason Not Completed
Adverse Event             71             15             132
Withdrawal by Subject             9             9             13
Non-Compliant             3             3             1
Lost to Follow-up             1             0             3
Lack of Efficacy             10             2             4
Disallowed Concurrent Medication             2             5             2
Physician Decision             1             2             2
Protocol Violation             4             10             6
Death             2             0             0
Other(Site,Sponsor and Subject request)             2             1             5
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID AR-13324 Ophthalmic Solution 0.02% 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 Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) 1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) Total of all reporting groups
Overall Number of Baseline Participants 251 251 254 756
Hide Baseline Analysis Population Description
The randomized population includes all subjects who were randomized to treatment. Baseline variables and demographic characteristics were summarized for this population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 251 participants 251 participants 254 participants 756 participants
65.3  (11.48) 63  (11.81) 64.1  (12.46) 64.1  (11.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants 251 participants 254 participants 756 participants
Female
148
  59.0%
150
  59.8%
165
  65.0%
463
  61.2%
Male
103
  41.0%
101
  40.2%
89
  35.0%
293
  38.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants 251 participants 254 participants 756 participants
Hispanic or Latino
41
  16.3%
42
  16.7%
43
  16.9%
126
  16.7%
Not Hispanic or Latino
210
  83.7%
209
  83.3%
211
  83.1%
630
  83.3%
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 251 participants 251 participants 254 participants 756 participants
American Indian or Alaska Native
2
   0.8%
0
   0.0%
0
   0.0%
2
   0.3%
Asian
2
   0.8%
6
   2.4%
6
   2.4%
14
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
69
  27.5%
76
  30.3%
69
  27.2%
214
  28.3%
White
178
  70.9%
166
  66.1%
177
  69.7%
521
  68.9%
More than one race
0
   0.0%
2
   0.8%
1
   0.4%
3
   0.4%
Unknown or Not Reported
0
   0.0%
1
   0.4%
1
   0.4%
2
   0.3%
1.Primary Outcome
Title Intraocular Pressure (IOP)
Hide Description The primary efficacy outcome is mean intraocular pressure (IOP)
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol (PP) population includes all subjects who did not have a major protocol violation likely to seriously affect the primary outcome of the study. This is the primary population for efficacy analyses.
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID AR-13324 Ophthalmic Solution 0.02% BID
Hide Arm/Group Description:
1 drop AR-13324 in the PM & 1 drop placebo in the AM, OU
1 drop Timolol maleate BID in the AM and PM, OU
1 drop AR-13324 BID in the AM and PM, OU
Overall Number of Participants Analyzed 206 217 209
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 1, 0800 hours 23.51  (1.654) 23.45  (1.601) 23.50  (1.671)
Day 1, 1000 hours 22.31  (2.131) 22.18  (2.089) 22.26  (2.103)
Day 1, 1600 hours 21.56  (2.338) 21.61  (2.369) 21.49  (2.279)
Day 15, 0800 hours 19.01  (2.979) 18.25  (2.736) 18.20  (3.491)
Day 15, 1000 hours 17.74  (3.089) 17.49  (2.796) 16.91  (3.087)
Day 15, 1600 hours 17.37  (2.830) 17.59  (2.935) 16.28  (2.925)
Day 43, 0800 hours 19.37  (3.749) 18.08  (2.614) 18.57  (3.206)
Day 43, 1000 hours 18.10  (3.335) 17.31  (2.805) 17.09  (3.028)
Day 43, 1600 hours 17.88  (2.888) 17.25  (2.813) 16.58  (3.095)
Day 90 (Month 3), 0800 hours 19.43  (3.761) 18.21  (2.819) 18.66  (3.460)
Day 90 (Month 3), 1000 hours 18.18  (3.571) 17.52  (2.777) 17.81  (3.330)
Day 90 (Month 3), 1600 hours 17.73  (3.386) 17.67  (2.879) 17.08  (3.112)
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 included all randomized subjects who received at least 1 dose of study medication and was used to summarize safety variables. The safety population summarized subjects as treated for purpose of analysis. One (1) subject did not receive study drug as randomized, shown in the Participant Flow
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID AR-13324 Ophthalmic Solution 0.02% BID
Hide Arm/Group Description:
1 drop AR-13324 in the PM and 1 drop placebo in the AM in both eyes
1 drop Timolol maleate BID in the AM and PM, OU
1 drop AR-13324 BID in the AM and PM, OU
Overall Number of Participants Analyzed 251 251 253
Mean (Standard Deviation)
Unit of Measure: days
259.7  (133.34) 324.5  (90.73) 185.2  (144.56)
Time Frame 1 year
Adverse Event Reporting Description The Safety Population included all randomized subjects who received at least 1 dose of study medication and was used to summarize safety variables. One (1) subject did not receive study drug as randomized, shown in the Participant Flow.
 
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID AR-13324 Ophthalmic Solution 0.02% BID
Hide Arm/Group Description 1 drop AR-13324 in the PM and 1 drop placebo in the AM, OU 1 drop Timolol maleate BID in the AM and PM, OU 1 drop AR-13324 BID in the AM and PM, OU
All-Cause Mortality
AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID AR-13324 Ophthalmic Solution 0.02% BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/251 (0.80%)   0/251 (0.00%)   0/253 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
AR-13324 Ophthalmic Solution 0.02% & Placebo Timolol Maleate Ophthalmic Solution 0.5% BID AR-13324 Ophthalmic Solution 0.02% BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/251 (6.77%)   12/251 (4.78%)   7/253 (2.77%) 
Cardiac disorders       
Coronary Artery Disease  1  2/251 (0.80%)  0/251 (0.00%)  1/253 (0.40%) 
Myocardial Infarction  1  2/251 (0.80%)  1/251 (0.40%)  1/253 (0.40%) 
Atrial Fibrillation  1  2/251 (0.80%)  0/251 (0.00%)  0/253 (0.00%) 
Atrial Flutter  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Bradycardia  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Eye disorders       
Cataract  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Gastrointestinal disorders       
Abdominal Pain  1  0/251 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Gastric Ulcer Perforation  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Cholecystitis  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Infections and infestations       
Cellulitis  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Peritonitis Bacterial  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Pneumonia  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Urinary Tract Infection  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Injury, poisoning and procedural complications       
Foot Fracture  1  0/251 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Postoperative Ileus  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Road Traffic Accident  1  0/251 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Fall  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Hip Fracture  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Ligament Rupture  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Tendon Rupture  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Investigations       
Prostatic Specific Antigen Increased  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Metabolism and nutrition disorders       
Fluid Overload  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back Pain  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Osteoarthritis  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Synovial Cyst  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast Cancer  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Malignant Melanoma in Situ  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Myelodysplastic Syndrome  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Prostate Cancer  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Nervous system disorders       
Cerebrovascular Accident  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Embolic Stroke  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Carotid Artery Stenosis  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Renal and urinary disorders       
Acute Kidney Injury  1  0/251 (0.00%)  1/251 (0.40%)  1/253 (0.40%) 
Renal Failure  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  0/251 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Pulmonary Artery Stenosis  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Pulmonary Embolism  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (0.00%) 
Skin and subcutaneous tissue disorders       
Angioedema  1  0/251 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Vascular disorders       
Accelerated Hypertension  1  1/251 (0.40%)  0/251 (0.00%)  0/253 (0.00%) 
Internal Haemorrhage  1  0/251 (0.00%)  0/251 (0.00%)  1/253 (0.40%) 
Peripheral Artery Occlusion  1  0/251 (0.00%)  1/251 (0.40%)  0/253 (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 AR-13324 Ophthalmic Solution 0.02% BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   198/251 (78.88%)   96/251 (38.25%)   213/253 (84.19%) 
Eye disorders       
Conjunctival Hyperaemia  1  152/251 (60.56%)  35/251 (13.94%)  168/253 (66.40%) 
Cornea Verticillata  1  64/251 (25.50%)  2/251 (0.80%)  64/253 (25.30%) 
Conjunctival Haemorrhage  1  49/251 (19.52%)  2/251 (0.80%)  49/253 (19.37%) 
Vision Blurred  1  27/251 (10.76%)  7/251 (2.79%)  44/253 (17.39%) 
Lacrimation Increased  1  19/251 (7.57%)  0/251 (0.00%)  25/253 (9.88%) 
Visual Acuity Reduced  1  22/251 (8.76%)  6/251 (2.39%)  22/253 (8.70%) 
Eye Pruritus  1  14/251 (5.58%)  3/251 (1.20%)  20/253 (7.91%) 
Conjunctival Oedema  1  8/251 (3.19%)  0/251 (0.00%)  19/253 (7.51%) 
Erythema of Eyelid  1  14/251 (5.58%)  2/251 (0.80%)  12/253 (4.74%) 
Eye Irritation  1  11/251 (4.38%)  8/251 (3.19%)  13/253 (5.14%) 
Foreign Body Sensation in Eyes  1  7/251 (2.79%)  1/251 (0.40%)  14/253 (5.53%) 
General disorders       
Instillation Site Pain  1  45/251 (17.93%)  41/251 (16.33%)  45/253 (17.79%) 
Instillation Site Erythema  1  14/251 (5.58%)  5/251 (1.99%)  32/253 (12.65%) 
Investigations       
Vital Dye Staining Cornea Present  1  14/251 (5.58%)  14/251 (5.58%)  17/253 (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
Layout table for Results Point of Contact information
Name/Title: Nancy Ramirez-Davis, Director of Clinical Project Management
Organization: Aerie Pharmaceuticals, Inc.
Phone: 908-947-3543
EMail: nramirez@aeriepharma.com
Layout table for additonal information
Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02207621     History of Changes
Other Study ID Numbers: AR-13324-CS302
First Submitted: July 31, 2014
First Posted: August 4, 2014
Results First Submitted: January 17, 2018
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018