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Trial record 12 of 21 for:    netarsudil

Study of AR-13324 in Patients With Elevated Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT01528787
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : February 21, 2018
Last Update Posted : April 18, 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 0.01%
Drug: AR-13324 Ophthalmic Solution 0.02%
Drug: AR-13324 Ophthalmic Solution 0.04%
Other: AR-13324 Ophthalmic Solution Vehicle
Enrollment 85
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AR-13324 Ophthalmic Solution 0.01% AR-13324 Ophthalmic Solution 0.02% AR-13324 Ophthalmic Solution 0.04% AR-13324 Opththalmic Solution Vehicle
Hide Arm/Group Description 1 drop to study eye once daily (QD) in the morning (AM) 1 drop to study eye once daily (QD) in the morning (AM) 1 drop to study eye once daily (QD) in the morning (AM) 1 drop to study eye once daily (QD) in the morning (AM)
Period Title: Overall Study
Started 22 21 19 23
Completed 22 21 18 22
Not Completed 0 0 1 1
Reason Not Completed
Withdrawal by Subject             0             0             0             1
Family Emergency             0             0             1             0
Arm/Group Title AR-13324 Ophthalmic Solution 0.01% AR-13324 Ophthalmic Solution 0.02% AR-13324 Ophthalmic Solution 0.04% AR-13324 Ophthalmic Solution Vehicle Total
Hide Arm/Group Description 1 drop to study eye once daily (QD) in the morning (AM) 1 drop to study eye once daily (QD) in the morning (AM) 1 drop to study eye once daily (QD) in the morning (AM) 1 drop to study eye once daily (QD) in the morning (AM) Total of all reporting groups
Overall Number of Baseline Participants 22 21 19 23 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 19 participants 23 participants 85 participants
63.6  (12.36) 69.1  (8.69) 66.1  (11.09) 57.8  (12.27) 64.0  (11.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 19 participants 23 participants 85 participants
Female
14
  63.6%
14
  66.7%
10
  52.6%
13
  56.5%
51
  60.0%
Male
8
  36.4%
7
  33.3%
9
  47.4%
10
  43.5%
34
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 19 participants 23 participants 85 participants
Hispanic or Latino
4
  18.2%
1
   4.8%
2
  10.5%
4
  17.4%
11
  12.9%
Not Hispanic or Latino
18
  81.8%
20
  95.2%
17
  89.5%
19
  82.6%
74
  87.1%
Unknown or Not Reported
0
   0.0%
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 22 participants 21 participants 19 participants 23 participants 85 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.5%
1
   4.8%
0
   0.0%
1
   4.3%
3
   3.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.5%
3
  14.3%
2
  10.5%
2
   8.7%
8
   9.4%
White
20
  90.9%
17
  81.0%
17
  89.5%
20
  87.0%
74
  87.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Intraocular Pressure (IOP)
Hide Description

The primary efficacy outcome was the mean IOP across subjects within treatment group at each post-treatment timepoint of Day 8.

Instillation of study treatment commenced on Day 2 following measurement of IOP. IOP was measured at 0800, 1000, 1200 and 1600 hours on days 2 and 8. IOP was also measured at 0800 hours on Day 4.

Time Frame Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (mITT) population (85 patients receiving investigational treatment). Participants who did not complete the study did not contribute data at later time points.
Arm/Group Title AR-13324 Ophthalmic Solution 0.01% AR-13324 Ophthalmic Solution 0.02% AR-13324 Ophthalmic Solution 0.04% AR-13324 Ophthalmic Solution Vehicle
Hide Arm/Group Description:
1 drop to study eye once daily (QD) in the morning (AM)
1 drop to study eye once daily (QD) in the morning (AM)
1 drop to study eye once daily (QD) in the morning (AM)
1 drop to study eye once daily (QD) in the morning (AM)
Overall Number of Participants Analyzed 22 21 19 23
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 2, 0800 hours Number Analyzed 22 participants 21 participants 19 participants 23 participants
25.80  (3.699) 26.02  (2.542) 26.50  (3.358) 25.17  (2.980)
Day 2, 1000 hours Number Analyzed 22 participants 21 participants 19 participants 23 participants
22.45  (3.713) 22.10  (3.149) 24.29  (5.347) 22.87  (2.681)
Day 2, 1200 hours Number Analyzed 22 participants 21 participants 19 participants 23 participants
21.93  (2.997) 21.95  (3.653) 25.00  (5.292) 22.91  (2.863)
Day 2, 1600 hours Number Analyzed 22 participants 21 participants 19 participants 23 participants
20.70  (3.521) 20.88  (3.467) 22.29  (4.849) 21.41  (3.110)
Day 4, 0800 hours Number Analyzed 22 participants 21 participants 19 participants 22 participants
21.32  (4.049) 21.00  (4.530) 22.00  (5.352) 23.98  (3.730)
Day 8, 0800 hours Number Analyzed 22 participants 21 participants 18 participants 22 participants
20.82  (5.487) 20.60  (3.491) 20.44  (3.933) 24.34  (3.663)
Day 8, 1000 hours Number Analyzed 22 participants 21 participants 18 participants 22 participants
18.20  (4.165) 18.71  (3.208) 19.42  (3.663) 22.34  (4.034)
Day 8, 1200 hours Number Analyzed 22 participants 21 participants 18 participants 22 participants
17.57  (4.255) 17.88  (3.457) 18.78  (4.486) 21.93  (3.818)
Day 8, 1600 hours Number Analyzed 22 participants 21 participants 18 participants 22 participants
17.68  (3.161) 16.88  (3.049) 17.83  (3.510) 21.52  (4.244)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AR-13324 Ophthalmic Solution 0.01% AR-13324 Ophthalmic Solution 0.02% AR-13324 Ophthalmic Solution 0.04% AR-13324 Ophthalmic Solution Vehicle
Hide Arm/Group Description 1 drop to study eye once daily (QD) in the morning (AM) 1 drop to study eye once daily (QD) in the morning (AM) 1 drop to study eye once daily (QD) in the morning (AM) 1 drop to study eye once daily (QD) in the morning (AM)
All-Cause Mortality
AR-13324 Ophthalmic Solution 0.01% AR-13324 Ophthalmic Solution 0.02% AR-13324 Ophthalmic Solution 0.04% AR-13324 Ophthalmic Solution Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/21 (0.00%)   0/19 (0.00%)   0/23 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
AR-13324 Ophthalmic Solution 0.01% AR-13324 Ophthalmic Solution 0.02% AR-13324 Ophthalmic Solution 0.04% AR-13324 Ophthalmic Solution Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/21 (0.00%)   0/19 (0.00%)   0/23 (0.00%) 
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 0.01% AR-13324 Ophthalmic Solution 0.02% AR-13324 Ophthalmic Solution 0.04% AR-13324 Ophthalmic Solution Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/22 (54.55%)   15/21 (71.43%)   17/19 (89.47%)   1/23 (4.35%) 
Ear and labyrinth disorders         
Vertigo  1  0/22 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
Eye disorders         
Conjunctival Hyperaemia  1  11/22 (50.00%)  12/21 (57.14%)  14/19 (73.68%)  1/23 (4.35%) 
Ocular Hyperaemia  1  1/22 (4.55%)  1/21 (4.76%)  3/19 (15.79%)  0/23 (0.00%) 
Erythema of Eyelid  1  0/22 (0.00%)  1/21 (4.76%)  1/19 (5.26%)  0/23 (0.00%) 
Vision Blurred  1  0/22 (0.00%)  2/21 (9.52%)  1/19 (5.26%)  0/23 (0.00%) 
Diplopia  1  0/22 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
Dry Eye  1  0/22 (0.00%)  2/21 (9.52%)  0/19 (0.00%)  0/23 (0.00%) 
Vitreous Floaters  1  0/22 (0.00%)  0/21 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
General disorders         
Instillation Site Reaction  1  0/22 (0.00%)  0/21 (0.00%)  2/19 (10.53%)  0/23 (0.00%) 
Investigations         
Corneal Staining  1  0/22 (0.00%)  2/21 (9.52%)  1/19 (5.26%)  0/23 (0.00%) 
Blood Glucose Increased  1  0/22 (0.00%)  1/21 (4.76%)  1/19 (5.26%)  0/23 (0.00%) 
1
Term from vocabulary, MedDRA (15.0)
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 Clinical Project Management
Organization: Aerie Pharmaceuticals, Inc.
Phone: 908-947-3543
Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01528787     History of Changes
Other Study ID Numbers: AR-13324-CS201
First Submitted: February 5, 2012
First Posted: February 8, 2012
Results First Submitted: January 22, 2018
Results First Posted: February 21, 2018
Last Update Posted: April 18, 2018