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Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT02246764
Recruitment Status : Completed
First Posted : September 23, 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
Glaucoma
Interventions Drug: AR-13324 Ophthalmic Solution 0.02%
Drug: AR-13324 Ophthalmic Solution 0.02% BID
Drug: Timolol maleate Ophthalmic Solution 0.5% BID
Other: Placebo
Enrollment 93
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo AR-13324 Ophthalmic Solution 0.02% BID 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 AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) 1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
Period Title: Overall Study
Started 34 36 23
Completed 16 4 19
Not Completed 18 32 4
Reason Not Completed
Adverse Event             15             29             1
Withdrawal by Subject             0             0             1
Disallowed Concomitant Medication             1             0             0
Physician Decision             0             2             1
Protocol Violation             2             1             1
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo AR-13324 Ophthalmic Solution 0.02% BID 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 AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) 1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) Total of all reporting groups
Overall Number of Baseline Participants 34 36 23 93
Hide Baseline Analysis Population Description
Randomized Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 36 participants 23 participants 93 participants
64.6  (7.73) 64.4  (7.84) 61.9  (12.52) 63.8  (9.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 36 participants 23 participants 93 participants
Female
18
  52.9%
18
  50.0%
8
  34.8%
44
  47.3%
Male
16
  47.1%
18
  50.0%
15
  65.2%
49
  52.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 36 participants 23 participants 93 participants
Hispanic or Latino
1
   2.9%
1
   2.8%
0
   0.0%
2
   2.2%
Not Hispanic or Latino
33
  97.1%
35
  97.2%
23
 100.0%
91
  97.8%
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 34 participants 36 participants 23 participants 93 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.8%
3
  13.0%
4
   4.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   8.8%
1
   2.8%
1
   4.3%
5
   5.4%
White
30
  88.2%
34
  94.4%
19
  82.6%
83
  89.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.9%
0
   0.0%
0
   0.0%
1
   1.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 34 participants 36 participants 23 participants 93 participants
34 36 23 93
1.Primary 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
Safety Population
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo AR-13324 Ophthalmic Solution 0.02% BID Timolol Maleate Ophthalmic Solution 0.5% 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 AR-13324 twice daily (BID) in the morning and evening (PM) in both eyes (OU)
1 drop Timolol maleate twice daily (BID) in the morning and evening (PM) in both eyes (OU)
Overall Number of Participants Analyzed 34 36 23
Mean (Standard Deviation)
Unit of Measure: days
224.4  (137.28) 101.8  (105.69) 314.6  (111.30)
Time Frame 1 year (12 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AR-13324 Ophthalmic Solution 0.02% & Placebo AR-13324 Ophthalmic Solution 0.02% BID 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 AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) 1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
All-Cause Mortality
AR-13324 Ophthalmic Solution 0.02% & Placebo AR-13324 Ophthalmic Solution 0.02% BID Timolol Maleate Ophthalmic Solution 0.5% BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/36 (0.00%)   0/23 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
AR-13324 Ophthalmic Solution 0.02% & Placebo AR-13324 Ophthalmic Solution 0.02% BID Timolol Maleate Ophthalmic Solution 0.5% BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   1/36 (2.78%)   1/23 (4.35%) 
Eye disorders       
Anterior Uveitis  1  0/34 (0.00%)  1/36 (2.78%)  0/23 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast Cancer  1  0/34 (0.00%)  0/36 (0.00%)  1/23 (4.35%) 
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 AR-13324 Ophthalmic Solution 0.02% BID Timolol Maleate Ophthalmic Solution 0.5% BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   33/34 (97.06%)   36/36 (100.00%)   15/23 (65.22%) 
Eye disorders       
Conjunctival Hyperaemia  1  28/34 (82.35%)  34/36 (94.44%)  2/23 (8.70%) 
Corneal Verticillata  1  13/34 (38.24%)  14/36 (38.89%)  0/23 (0.00%) 
Erythema of Eyelid  1  5/34 (14.71%)  10/36 (27.78%)  2/23 (8.70%) 
Conjunctival Haemorrhage  1  7/34 (20.59%)  6/36 (16.67%)  0/23 (0.00%) 
Eyelid Oedema  1  4/34 (11.76%)  7/36 (19.44%)  0/23 (0.00%) 
Lacrimation Increased  1  7/34 (20.59%)  4/36 (11.11%)  0/23 (0.00%) 
Corneal Opacity  1  5/34 (14.71%)  4/36 (11.11%)  0/23 (0.00%) 
Blepharitis  1  2/34 (5.88%)  5/36 (13.89%)  0/23 (0.00%) 
Vision Blurred  1  2/34 (5.88%)  5/36 (13.89%)  0/23 (0.00%) 
Conjunctival Oedema  1  3/34 (8.82%)  3/36 (8.33%)  0/23 (0.00%) 
Eye Pruritis  1  3/34 (8.82%)  3/36 (8.33%)  0/23 (0.00%) 
Eye Pain  1  2/34 (5.88%)  3/36 (8.33%)  1/23 (4.35%) 
Eye Irritation  1  1/34 (2.94%)  3/36 (8.33%)  0/23 (0.00%) 
Eyelids Pruritus  1  1/34 (2.94%)  3/36 (8.33%)  0/23 (0.00%) 
Foreign Body Sensation in Eye  1  0/34 (0.00%)  4/36 (11.11%)  0/23 (0.00%) 
Lenticular Opacities  1  3/34 (8.82%)  1/36 (2.78%)  0/23 (0.00%) 
Conjunctivochalasis  1  2/34 (5.88%)  1/36 (2.78%)  0/23 (0.00%) 
Eye Discharge  1  2/34 (5.88%)  1/36 (2.78%)  0/23 (0.00%) 
Photophobia  1  2/34 (5.88%)  1/36 (2.78%)  0/23 (0.00%) 
Conjunctivitis Allergic  1  0/34 (0.00%)  2/36 (5.56%)  0/23 (0.00%) 
Eye Allergy  1  2/34 (5.88%)  0/36 (0.00%)  0/23 (0.00%) 
Eyelid Pain  1  0/34 (0.00%)  2/36 (5.56%)  0/23 (0.00%) 
Optic Disc Haemorrhage  1  0/34 (0.00%)  2/36 (5.56%)  1/23 (4.35%) 
Dry Eye  1  1/34 (2.94%)  0/36 (0.00%)  2/23 (8.70%) 
Gastrointestinal disorders       
Nausea  1  0/34 (0.00%)  2/36 (5.56%)  0/23 (0.00%) 
General disorders       
Instillation Site Pain  1  9/34 (26.47%)  8/36 (22.22%)  6/23 (26.09%) 
Instillation Site Discomfort  1  6/34 (17.65%)  2/36 (5.56%)  1/23 (4.35%) 
Instillation Site Erythema  1  2/34 (5.88%)  2/36 (5.56%)  0/23 (0.00%) 
Instillation Site Pruritus  1  2/34 (5.88%)  0/36 (0.00%)  0/23 (0.00%) 
Infections and infestations       
Nasopharyngitis  1  2/34 (5.88%)  1/36 (2.78%)  0/23 (0.00%) 
Hordeolum  1  0/34 (0.00%)  0/36 (0.00%)  2/23 (8.70%) 
Conjunctivitis  1  2/34 (5.88%)  0/36 (0.00%)  0/23 (0.00%) 
Investigations       
Vital Dye Staining Cornea Present  1  14/34 (41.18%)  8/36 (22.22%)  7/23 (30.43%) 
Intraocular Pressure Increased  1  3/34 (8.82%)  1/36 (2.78%)  0/23 (0.00%) 
Blood Triglycerides Increased  1  2/34 (5.88%)  0/36 (0.00%)  0/23 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  3/34 (8.82%)  0/36 (0.00%)  1/23 (4.35%) 
Nervous system disorders       
Headache  1  1/34 (2.94%)  3/36 (8.33%)  1/23 (4.35%) 
Dizziness  1  0/34 (0.00%)  2/36 (5.56%)  0/23 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis Allergic  1  0/34 (0.00%)  2/36 (5.56%)  0/23 (0.00%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Enrollment was discontinued after 93 participants were enrolled due to slow enrollment; all participants who entered the study were followed until study completion.
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 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: NCT02246764     History of Changes
Other Study ID Numbers: AR-13324-CS303
First Submitted: September 16, 2014
First Posted: September 23, 2014
Results First Submitted: January 17, 2018
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018