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Trial record 3 of 22 for:    netarsudil

Nocturnal/Diurnal Intraocular Pressure-Lowering Effect of Netarsudil Ophthalmic Solution

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: NCT02874846
Recruitment Status : Completed
First Posted : August 22, 2016
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: Netarsudil ophthalmic solution 0.02%
Other: Netarsudil Ophthalmic Solution Vehicle
Enrollment 12
Recruitment Details  
Pre-assignment Details Subjects who agreed to participate in this study were assessed during a screening visit and those who were already using ocular hypotensive medication had to undergo a washout for a specified period (5 days to 4 weeks, depending on the medication) prior to the Qualification visit.
Arm/Group Title Netarsudil Ophthalmic Solution 0.02% Netarsudil Ophthalmic Solution Vehicle
Hide Arm/Group Description 1 drop in each eye (OU) daily in the evening (PM) 1 drop in each eye (OU) daily in the evening (PM)
Period Title: Overall Study
Started 8 4
Completed 8 4
Not Completed 0 0
Arm/Group Title Netarsudil Ophthalmic Solution 0.02% Netarsudil Ophthalmic Solution Vehicle Total
Hide Arm/Group Description 1 drop in each eye daily (OU) in the evening (PM) 1 drop in each eye daily (OU) in the evening Total of all reporting groups
Overall Number of Baseline Participants 8 4 12
Hide Baseline Analysis Population Description
ITT
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 4 participants 12 participants
64.4  (10.23) 64.5  (5.07) 64.4  (8.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
Female
4
  50.0%
2
  50.0%
6
  50.0%
Male
4
  50.0%
2
  50.0%
6
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
Hispanic or Latino
1
  12.5%
1
  25.0%
2
  16.7%
Not Hispanic or Latino
7
  87.5%
3
  75.0%
10
  83.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  75.0%
3
  75.0%
9
  75.0%
White
2
  25.0%
1
  25.0%
3
  25.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change in Intraocular Pressure (IOP) Over Nocturnal Time Period
Hide Description The primary efficacy endpoint was the mean change from baseline in mean nocturnal IOP (defined as the mean of the 4 nocturnal time points: 21:00, 00:00, 03:00, and 06:00 hours) on Day 8/Day 9
Time Frame Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Netarsudil Ophthalmic Solution 0.02% Netarsudil Ophthalmic Solution Vehicle
Hide Arm/Group Description:
1 drop in each eye (OU) daily in the evening (PM)
1 drop in each eye (OU) daily in the evening
Overall Number of Participants Analyzed 8 4
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (Day 1/2); nocturnal mean 22.84  (2.21) 23.56  (1.94)
Visit 4 (Day 8/9); nocturnal mean 19.38  (2.86) 23.19  (1.95)
2.Secondary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Hide Description [Not Specified]
Time Frame 7 days (day 1/2 to day 8/9)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Netarsudil Ophthalmic Solution 0.02% Netarsudil Ophthalmic Solution Vehicle
Hide Arm/Group Description:
1 drop in each eye (OU) daily in the evening (PM)
1 drop in each eye (OU) daily in the evening (PM)
Overall Number of Participants Analyzed 8 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Adverse event data was collected over 7 days from day 1/2 to day 8/9.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Netarsudil Ophthalmic Solution 0.02% Netarsudil Ophthalmic Solution Vehicle
Hide Arm/Group Description 1 drop in each eye (OU) daily in the evening (PM) 1 drop in each eye (OU) daily in the evening (PM)
All-Cause Mortality
Netarsudil Ophthalmic Solution 0.02% Netarsudil Ophthalmic Solution Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Netarsudil Ophthalmic Solution 0.02% Netarsudil Ophthalmic Solution Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/4 (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% Netarsudil Ophthalmic Solution Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/4 (0.00%) 
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: NCT02874846     History of Changes
Other Study ID Numbers: AR-13324-CS204
First Submitted: August 15, 2016
First Posted: August 22, 2016
Results First Submitted: January 23, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018