Trial Outcomes & Findings for Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) (NCT NCT03233308)
NCT ID: NCT03233308
Last Updated: 2019-08-06
Results Overview
Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Study treatment was administered for 7 days, and outcome measures collected on Day 8
Results posted on
2019-08-06
Participant Flow
Participant milestones
| Measure |
All Randomized Patients
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 Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
All Randomized Patients
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 Study
Adverse Event
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Baseline characteristics by cohort
| Measure |
All Randomized Patients
n=20 Participants
1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and placebo comparator to the contralateral eye
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=39 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 12.53 • n=39 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Study treatment was administered for 7 days, and outcome measures collected on Day 8Population: Modified intent-to-treat (mITT) population
Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
Outcome measures
| Measure |
Netarsudil Ophthalmic Solution 0.02%
n=18 Participants
Netarsudil Ophthalmic Solution 0.02% was administered in one eye
|
Placebo Comparator
n=18 Participants
Placebo Comparator administered in contralateral eye
|
|---|---|---|
|
Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility
|
0.039 mcl/min/mmHg
Standard Deviation 0.0401
|
0.007 mcl/min/mmHg
Standard Deviation 0.0275
|
PRIMARY outcome
Timeframe: Study treatment was administered for 7 days, and outcome measures collected on Day 8Population: Modified intent-to-treat (mITT) population
Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
Outcome measures
| Measure |
Netarsudil Ophthalmic Solution 0.02%
n=18 Participants
Netarsudil Ophthalmic Solution 0.02% was administered in one eye
|
Placebo Comparator
n=18 Participants
Placebo Comparator administered in contralateral eye
|
|---|---|---|
|
Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility.
|
34.589 percentage change
Standard Deviation 34.5935
|
9.597 percentage change
Standard Deviation 25.6334
|
SECONDARY outcome
Timeframe: Study treatment was administered for 7 days, and outcome measures collected on Day 8Population: Modified intent-to-treat (mITT) population, EVP analyzed in 9 participants
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)
Outcome measures
| Measure |
Netarsudil Ophthalmic Solution 0.02%
n=18 Participants
Netarsudil Ophthalmic Solution 0.02% was administered in one eye
|
Placebo Comparator
n=18 Participants
Placebo Comparator administered in contralateral eye
|
|---|---|---|
|
Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)
Diurnal EVP (delta vs.baseline)
|
-0.787 mmHg
Standard Deviation 0.8372
|
0.103 mmHg
Standard Deviation 0.7094
|
|
Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)
Diurnal IOP (delta vs.baseline)
|
-4.521 mmHg
Standard Deviation 1.5842
|
-0.979 mmHg
Standard Deviation 1.6009
|
SECONDARY outcome
Timeframe: Study treatment was administered for 7 days, and outcome measures collected on Day 8Population: Modified intent-to-treat (mITT) population, EVP analyzed in 9 participants
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)
Outcome measures
| Measure |
Netarsudil Ophthalmic Solution 0.02%
n=18 Participants
Netarsudil Ophthalmic Solution 0.02% was administered in one eye
|
Placebo Comparator
n=18 Participants
Placebo Comparator administered in contralateral eye
|
|---|---|---|
|
Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)
Percent change from baseline (EVP)
|
-9.465 percentage change
Standard Deviation 9.5044
|
3.103 percentage change
Standard Deviation 7.7322
|
|
Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)
Percent change from baseline (IOP)
|
-19.568 percentage change
Standard Deviation 6.0713
|
-4.227 percentage change
Standard Deviation 6.9699
|
Adverse Events
Netarsudil Ophthalmic Solution 0.02%
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Netarsudil Ophthalmic Solution 0.02%
n=20 participants at risk
Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye
|
Placebo Comparator
n=20 participants at risk
Placebo comparator was administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye
|
|---|---|---|
|
Eye disorders
Conjunctival Hyperaemia
|
65.0%
13/20 • Number of events 13 • 7 Days
|
0.00%
0/20 • 7 Days
|
|
Eye disorders
Eye Irritation
|
15.0%
3/20 • Number of events 3 • 7 Days
|
0.00%
0/20 • 7 Days
|
|
Eye disorders
Vision Blurred
|
10.0%
2/20 • Number of events 2 • 7 Days
|
0.00%
0/20 • 7 Days
|
|
Eye disorders
Eye Swelling
|
5.0%
1/20 • Number of events 1 • 7 Days
|
0.00%
0/20 • 7 Days
|
|
Eye disorders
Photophobia
|
5.0%
1/20 • Number of events 1 • 7 Days
|
0.00%
0/20 • 7 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place