Trial Outcomes & Findings for Nocturnal/Diurnal Intraocular Pressure-Lowering Effect of Netarsudil Ophthalmic Solution (NCT NCT02874846)

Last Updated: 2018-04-17

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9

Results posted on

2018-04-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Netarsudil Ophthalmic Solution 0.02% 1 drop in each eye (OU) daily in the evening (PM)	Netarsudil Ophthalmic Solution Vehicle 1 drop in each eye (OU) daily in the evening (PM)
Overall Study STARTED	8	4
Overall Study COMPLETED	8	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Netarsudil Ophthalmic Solution 0.02% n=8 Participants 1 drop in each eye daily (OU) in the evening (PM)	Netarsudil Ophthalmic Solution Vehicle n=4 Participants 1 drop in each eye daily (OU) in the evening	Total n=12 Participants Total of all reporting groups
Age, Continuous	64.4 years STANDARD_DEVIATION 10.23 • n=5 Participants	64.5 years STANDARD_DEVIATION 5.07 • n=7 Participants	64.4 years STANDARD_DEVIATION 8.58 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9

Population: ITT

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

Outcome measures

Outcome measures
Measure	Netarsudil Ophthalmic Solution 0.02% n=8 Participants 1 drop in each eye (OU) daily in the evening (PM)	Netarsudil Ophthalmic Solution Vehicle n=4 Participants 1 drop in each eye (OU) daily in the evening
Change in Intraocular Pressure (IOP) Over Nocturnal Time Period Baseline (Day 1/2); nocturnal mean	22.84 mmHg Standard Deviation 2.21	23.56 mmHg Standard Deviation 1.94
Change in Intraocular Pressure (IOP) Over Nocturnal Time Period Visit 4 (Day 8/9); nocturnal mean	19.38 mmHg Standard Deviation 2.86	23.19 mmHg Standard Deviation 1.95

SECONDARY outcome

Timeframe: 7 days (day 1/2 to day 8/9)

Population: ITT

Outcome measures

Outcome measures
Measure	Netarsudil Ophthalmic Solution 0.02% n=8 Participants 1 drop in each eye (OU) daily in the evening (PM)	Netarsudil Ophthalmic Solution Vehicle n=4 Participants 1 drop in each eye (OU) daily in the evening
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	0 Participants	0 Participants

Adverse Events

Netarsudil Ophthalmic Solution 0.02%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Netarsudil Ophthalmic Solution Vehicle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Ramirez-Davis, Director of Clinical Project Management

Aerie Pharmaceuticals, Inc.

Phone: 908-947-3543

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place