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Trial record 14 of 22 for:    netarsudil

Study Comparing the Safety and Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT01731002
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : April 17, 2018
Last Update Posted : April 17, 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: Latanoprost ophthalmic solution 0.005%
Enrollment 224
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AR-13324 Ophthalmic Solution 0.01% AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Hide Arm/Group Description 1 drop to study eye once daily (QD) in the evening (PM) 1 drop to study eye once daily (QD) in the evening (PM) 1 drop to study eye once daily (QD) in the evening (PM)
Period Title: Overall Study
Started 75 72 77
Completed 71 68 74
Not Completed 4 4 3
Reason Not Completed
Adverse Event             0             2             2
Non-Compliant             0             1             0
Lost to Follow-up             1             0             0
Test Agent Discontinuation             0             1             0
Uncontrolled Intraocular Pressure (IOP)             2             0             0
Elevated IOP             1             0             0
Inappropriate use of study medications             0             0             1
Arm/Group Title AR-13324 Ophthalmic Solution 0.01% AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005% Total
Hide Arm/Group Description 1 drop to study eye once daily (QD) in the evening (PM) 1 drop to study eye once daily (QD) in the evening (PM) 1 drop to study eye once daily (QD) in the evening (PM) Total of all reporting groups
Overall Number of Baseline Participants 75 72 77 224
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 72 participants 77 participants 224 participants
63.5  (11.54) 66.3  (10.25) 65.7  (11.82) 65.1  (11.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 72 participants 77 participants 224 participants
Female
42
  56.0%
45
  62.5%
45
  58.4%
132
  58.9%
Male
33
  44.0%
27
  37.5%
32
  41.6%
92
  41.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 72 participants 77 participants 224 participants
Hispanic or Latino
16
  21.3%
15
  20.8%
15
  19.5%
46
  20.5%
Not Hispanic or Latino
59
  78.7%
57
  79.2%
62
  80.5%
178
  79.5%
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 75 participants 72 participants 77 participants 224 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.7%
2
   2.8%
0
   0.0%
4
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
17
  22.7%
16
  22.2%
19
  24.7%
52
  23.2%
White
56
  74.7%
53
  73.6%
58
  75.3%
167
  74.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.4%
0
   0.0%
1
   0.4%
1.Primary Outcome
Title Intraocular Pressure (IOP)
Hide Description The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30.
Time Frame Study treatment was administered for 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent to treat (mITT) population (3 subjects were excluded, leaving 221)
Arm/Group Title AR-13324 Ophthalmic Solution 0.01% AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Hide Arm/Group Description:
1 drop to study eye once daily (QD) in the evening (PM)
1 drop to study eye once daily (QD) in the evening (PM)
1 drop to study eye once daily (QD) in the evening (PM)
Overall Number of Participants Analyzed 74 71 76
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 0, 0800 hours 27.34  (3.529) 27.11  (3.031) 26.78  (2.749)
Day 0, 1000 hours 25.55  (3.411) 25.41  (3.024) 25.18  (2.719)
Day 0, 1600 hours 24.49  (3.128) 24.29  (2.602) 24.58  (2.515)
Day 7, 0800 hours 21.89  (4.672) 21.15  (4.047) 20.03  (3.173)
Day 14, 0800 hours 21.24  (4.295) 20.80  (3.679) 19.30  (3.033)
Day 14, 1000 hours 19.28  (3.581) 18.88  (3.461) 18.09  (2.884)
Day 14, 1600 hours 18.90  (3.578) 18.72  (3.585) 17.86  (2.977)
Day 28, 0800 hours 21.95  (4.717) 21.24  (4.034) 19.24  (2.899)
Day 28, 1000 hours 19.69  (4.358) 19.53  (3.726) 18.40  (2.994)
Day 28, 1600 hours 18.82  (3.281) 19.13  (3.656) 18.34  (3.052)
2.Secondary Outcome
Title Extent of Exposure
Hide Description Exposure to study medication in days for all treatment groups.
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AR-13324 Ophthalmic Solution 0.01% AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Hide Arm/Group Description:
1 drop to study eye once daily (QD) in the evening (PM)
1 drop to study eye once daily (QD) in the evening (PM)
1 drop to study eye once daily (QD) in the evening (PM)
Overall Number of Participants Analyzed 75 72 77
Mean (Standard Deviation)
Unit of Measure: days
27.6  (4.07) 26.8  (4.6) 27.8  (1.35)
Time Frame 28 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AR-13324 Ophthalmic Solution 0.01% AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Hide Arm/Group Description 1 drop to study eye once daily (QD) in the evening (PM) 1 drop to study eye once daily (QD) in the evening (PM) 1 drop to study eye once daily (QD) in the evening (PM)
All-Cause Mortality
AR-13324 Ophthalmic Solution 0.01% AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/75 (1.33%)   0/72 (0.00%)   0/77 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
AR-13324 Ophthalmic Solution 0.01% AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/75 (1.33%)   0/72 (0.00%)   2/77 (2.60%) 
Infections and infestations       
Pneumonia Streptococcal  1  0/75 (0.00%)  0/72 (0.00%)  1/77 (1.30%) 
Injury, poisoning and procedural complications       
Fall  1  0/75 (0.00%)  0/72 (0.00%)  1/77 (1.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acute Leukaemia  1  1/75 (1.33%)  0/72 (0.00%)  0/77 (0.00%) 
1
Term from vocabulary, MedDRA (15.1)
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 0.01% AR-13324 Ophthalmic Solution 0.02% Latanoprost Ophthalmic Solution 0.005%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   43/75 (57.33%)   45/72 (62.50%)   18/77 (23.38%) 
Eye disorders       
Conjunctival Hyperaemia  1  29/75 (38.67%)  34/72 (47.22%)  12/77 (15.58%) 
Ocular Hyperaemia  1  10/75 (13.33%)  7/72 (9.72%)  0/77 (0.00%) 
Lacrimation Increased  1  4/75 (5.33%)  5/72 (6.94%)  0/77 (0.00%) 
Conjunctival Haemorrhage  1  4/75 (5.33%)  4/72 (5.56%)  0/77 (0.00%) 
Foreign Body Sensation in Eyes  1  0/75 (0.00%)  5/72 (6.94%)  3/77 (3.90%) 
General disorders       
Instillation Site Pain  1  5/75 (6.67%)  9/72 (12.50%)  4/77 (5.19%) 
1
Term from vocabulary, MedDRA (15.1)
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: NCT01731002     History of Changes
Other Study ID Numbers: AR-13324-CS202
First Submitted: November 15, 2012
First Posted: November 21, 2012
Results First Submitted: January 22, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018