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Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

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ClinicalTrials.gov Identifier: NCT03233308
Recruitment Status : Completed
First Posted : July 28, 2017
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Primary Open Angle Glaucoma or Ocular Hypertension
Interventions Drug: Netarsudil Ophthalmic Solution 0.02%
Other: Placebo Comparator
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Randomized Patients
Hide Arm/Group Description 1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye
Period Title: Overall Study
Started 20
Completed 18
Not Completed 2
Reason Not Completed
Adverse Event             1
Protocol Violation             1
Arm/Group Title All Randomized Patients
Hide Arm/Group Description 1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and placebo comparator to the contralateral eye
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Modified intent-to-treat (mITT) population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  45.0%
>=65 years
11
  55.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
63  (12.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
14
  70.0%
Male
6
  30.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
1
   5.0%
Not Hispanic or Latino
19
  95.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  25.0%
White
14
  70.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility
Hide Description Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
Time Frame Study treatment was administered for 7 days, and outcome measures collected on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population
Arm/Group Title Netarsudil Ophthalmic Solution 0.02% Placebo Comparator
Hide Arm/Group Description:
Netarsudil Ophthalmic Solution 0.02% was administered in one eye
Placebo Comparator administered in contralateral eye
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: mcl/min/mmHg
0.039  (0.0401) 0.007  (0.0275)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Netarsudil Ophthalmic Solution 0.02%
Comments Mean Change from Baseline (difference from placebo)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
2.Primary Outcome
Title Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility.
Hide Description Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
Time Frame Study treatment was administered for 7 days, and outcome measures collected on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population
Arm/Group Title Netarsudil Ophthalmic Solution 0.02% Placebo Comparator
Hide Arm/Group Description:
Netarsudil Ophthalmic Solution 0.02% was administered in one eye
Placebo comparator administered in contralateral eye
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: percentage change from baseline
34.589  (34.5935) 9.597  (25.6334)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Netarsudil Ophthalmic Solution 0.02%
Comments Mean change from baseline (percent difference from baseline)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)
Hide Description Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants)
Time Frame Study treatment was administered for 7 days, and outcome measures collected on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population, EVP analyzed in 9 participants
Arm/Group Title Netarsudil Ophthalmic Solution 0.02% Placebo Comparator
Hide Arm/Group Description:
Netarsudil Ophthalmic Solution 0.02% administered to one eye and placebo to the contralateral eye
Placebo Comparator administered to one eye and Netarsudil Ophthalmic Solution 0.02% to the contralateral eye
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: mmHg
Diurnal EVP (delta vs.baseline) Number Analyzed 9 participants 9 participants
-0.787  (0.8372) 0.103  (0.7094)
Diurnal IOP (delta vs.baseline) Number Analyzed 18 participants 18 participants
-4.521  (1.5842) -0.979  (1.6009)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Netarsudil Ophthalmic Solution 0.02%
Comments Mean change from baseline (difference from placebo) -EVP
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0687
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Netarsudil Ophthalmic Solution 0.02%
Comments Mean change from baseline (difference from placebo)-IOP
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
4.Secondary Outcome
Title Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)
Hide Description Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants)
Time Frame Study treatment was administered for 7 days, and outcome measures collected on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population, EVP analyzed in 9 participants
Arm/Group Title Netarsudil Ophthalmic Solution 0.02% Placebo Comparator
Hide Arm/Group Description:
Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye
Placebo comparator administered to one eye and Netarsudil Ophthalmic Solution 0.02% to the contralateral eye
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: percentage change from baseline
Percent change from baseline (EVP) Number Analyzed 9 participants 9 participants
-9.465  (9.5044) 3.103  (7.7322)
Percent change from baseline (IOP) Number Analyzed 18 participants 18 participants
-19.568  (6.0713) -4.227  (6.9699)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Netarsudil Ophthalmic Solution 0.02%
Comments Mean change from baseline (percent difference from baseline) -EVP
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0087
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Netarsudil Ophthalmic Solution 0.02%
Comments Mean change from baseline (percent difference from baseline)- IOP
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Time Frame 7 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Netarsudil Ophthalmic Solution 0.02% Placebo Comparator
Hide Arm/Group Description Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye Placebo comparator was administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye
All-Cause Mortality
Netarsudil Ophthalmic Solution 0.02% Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Netarsudil Ophthalmic Solution 0.02% Placebo Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Netarsudil Ophthalmic Solution 0.02% Placebo Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/20 (65.00%)      0/20 (0.00%)    
Eye disorders     
Conjunctival Hyperaemia  1  13/20 (65.00%)  13 0/20 (0.00%)  0
Eye Irritation  1  3/20 (15.00%)  3 0/20 (0.00%)  0
Vision Blurred  1  2/20 (10.00%)  2 0/20 (0.00%)  0
Eye Swelling  1  1/20 (5.00%)  1 0/20 (0.00%)  0
Photophobia  1  1/20 (5.00%)  1 0/20 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
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: Theresa GH Heah, MD, MBA
Organization: Aerie Pharmaceuticals, Inc
Phone: 908-947-3844
Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03233308     History of Changes
Other Study ID Numbers: AR-13324-CS206
First Submitted: July 12, 2017
First Posted: July 28, 2017
Results First Submitted: April 18, 2019
Results First Posted: June 11, 2019
Last Update Posted: June 11, 2019