Trial Outcomes & Findings for Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting (NCT NCT03808688)
NCT ID: NCT03808688
Last Updated: 2020-09-29
Results Overview
Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry. Prostaglandin analog (PGA). Fixed dose combination (FDC).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
261 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-09-29
Participant Flow
A total of 261 subjects were enrolled across 22 investigational sites and 260 treated.
The enrolled population includes all subjects who signed ICF. One subject enrolled but withdrew consent before study drug dispensed; thus, post-baseline treatment is unavailable. Participant Flow data represents ITT population. Clarification of enrolled (n= 261) vs treated (n=260) subjects is provided in Recruitment \& Pre-assignment sections.
Participant milestones
| Measure |
Netarsudil Ophthalmic Solution 0.02% Monotherapy
Netarsudil Ophthalmic Solution 0.02% Monotherapy: 1 drop in each eye once daily in the evening.
|
Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy
Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
161
|
|
Overall Study
COMPLETED
|
81
|
138
|
|
Overall Study
NOT COMPLETED
|
18
|
23
|
Reasons for withdrawal
| Measure |
Netarsudil Ophthalmic Solution 0.02% Monotherapy
Netarsudil Ophthalmic Solution 0.02% Monotherapy: 1 drop in each eye once daily in the evening.
|
Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy
Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
17
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Intolerance to Conjunctival Hyperemia
|
1
|
0
|
|
Overall Study
IOP Too High
|
1
|
1
|
|
Overall Study
IOP Too High, Nerve/Visual Field Changes
|
0
|
1
|
|
Overall Study
Visit Out of Window
|
0
|
1
|
|
Overall Study
Medication Non-Compliance
|
0
|
1
|
Baseline Characteristics
Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting
Baseline characteristics by cohort
| Measure |
Netarsudil Ophthalmic Solution 0.02% Monotherapy
n=91 Participants
Netarsudil Ophthalmic Solution 0.02% Monotherapy - 1 drop in each eye once daily in the evening.
|
Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy
n=151 Participants
Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 11.85 • n=93 Participants
|
67.2 years
STANDARD_DEVIATION 10.53 • n=4 Participants
|
67.2 years
STANDARD_DEVIATION 11.02 • n=27 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=93 Participants
|
91 Participants
n=4 Participants
|
148 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
94 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=93 Participants
|
143 Participants
n=4 Participants
|
223 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
179 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Modified Intent-to-Treat (mITT) population included all subjects who received at least 1 dose of study medication and had at least 1 follow-up visit with a completed IOP measurement.
Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry. Prostaglandin analog (PGA). Fixed dose combination (FDC).
Outcome measures
| Measure |
Netarsudil Ophth Sol 0.02% Monotherapy - Tx Naïve At Baseline
n=24 Participants
During study Netarsudil Ophthalmic Solution 0.02% Monotherapy - Treatment naïve at baseline visit. 1 drop in each eye once daily in the evening.
|
Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 1 Agent
n=61 Participants
During study Netarsudil Ophthalmic Solution 0.02% Monotherapy - Replaced 1 agent at baseline visit (majority were PGA replacements). 1 drop in each eye once daily in the evening.
|
Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 2 Agents
n=6 Participants
During study Netarsudil Ophthalmic Solution 0.02% Monotherapy - Replaced 2 agents at baseline visit (including PGA and FDC replacements). 1 drop in each eye once daily in the evening.
|
Netarsudil Ophth Sol 0.02% Concomitant Therapy
n=151 Participants
During study Netarsudil Ophthalmic Solution 0.02% - Used concomitantly with other IOP lowering agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
|
|---|---|---|---|---|
|
Intraocular Pressure (IOP)
|
-16.9 percent change
Standard Deviation 16.35
|
-2.3 percent change
Standard Deviation 16.23
|
0.2 percent change
Standard Deviation 8.81
|
-17.0 percent change
Standard Deviation 16.81
|
Adverse Events
Netarsudil Ophthalmic Solution 0.02% Monotherapy
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy
Serious events: 1 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Netarsudil Ophthalmic Solution 0.02% Monotherapy
n=99 participants at risk
Netarsudil Ophthalmic Solution 0.02% Monotherapy. 1 drop in each eye once daily in the evening.
|
Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy
n=161 participants at risk
Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
|
|---|---|---|
|
Infections and infestations
Cellulitis Lower Left Extremity
|
0.00%
0/99 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
0.62%
1/161 • Number of events 1 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma of Eyelid
|
1.0%
1/99 • Number of events 1 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
0.00%
0/161 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
1.0%
1/99 • Number of events 1 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
0.00%
0/161 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Netarsudil Ophthalmic Solution 0.02% Monotherapy
n=99 participants at risk
Netarsudil Ophthalmic Solution 0.02% Monotherapy. 1 drop in each eye once daily in the evening.
|
Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy
n=161 participants at risk
Netarsudil Ophthalmic Solution 0.02% - Used Concomitantly With Other IOP Lowering Agents (2-5 total agents used). 1 drop in each eye once daily in the evening.
|
|---|---|---|
|
Eye disorders
Conjunctival Hyperemia
|
22.2%
22/99 • Number of events 22 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
19.9%
32/161 • Number of events 32 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
|
Eye disorders
Vision Blurred
|
9.1%
9/99 • Number of events 9 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
6.2%
10/161 • Number of events 10 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
|
Eye disorders
Conjunctival Hemorrage
|
6.1%
6/99 • Number of events 6 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
5.0%
8/161 • Number of events 8 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
|
Eye disorders
Instillation Site Pain
|
6.1%
6/99 • Number of events 6 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
5.0%
8/161 • Number of events 8 • Adverse event data was collected during the course of the 12-week treatment period.
The safety population included all subjects who received at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place