Trial Outcomes & Findings for Rocklatan® Evaluation (NCT NCT05283395)
NCT ID: NCT05283395
Last Updated: 2024-04-03
Results Overview
IOP was measured using Goldmann applanation tonometry at the Baseline and Week 12 visits. One eye (study eye) contributed data to this analysis. A negative value indicates an improvement in IOP. No hypothesis testing was prespecified for this endpoint.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
136 participants
Primary outcome timeframe
Baseline (Day 0 pretreatment), Week 12
Results posted on
2024-04-03
Participant Flow
Participants were recruited from 21 investigative sites located in the United States.
This reporting population includes all participants who received at least 1 dose of study medication.
Participant milestones
| Measure |
Rocklatan (Latanoprost Mono)
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost Mono medical therapy regimen)
|
Rocklatan (Latanoprost +1)
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +1 medical therapy regimen)
|
Rocklatan (Latanoprost +2)
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +2 medical therapy regimen)
|
|---|---|---|---|
|
Overall Study
STARTED
|
61
|
45
|
30
|
|
Overall Study
COMPLETED
|
54
|
37
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
5
|
Reasons for withdrawal
| Measure |
Rocklatan (Latanoprost Mono)
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost Mono medical therapy regimen)
|
Rocklatan (Latanoprost +1)
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +1 medical therapy regimen)
|
Rocklatan (Latanoprost +2)
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +2 medical therapy regimen)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
0
|
|
Overall Study
Patient Lost to Follow-Up
|
0
|
0
|
1
|
|
Overall Study
Patient Withdrawal
|
2
|
4
|
2
|
|
Overall Study
Investigator Decision
|
1
|
0
|
1
|
|
Overall Study
Enrolled in error
|
0
|
0
|
1
|
Baseline Characteristics
Rocklatan® Evaluation
Baseline characteristics by cohort
| Measure |
Rocklatan (Latanoprost Mono)
n=61 Participants
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost mono medical therapy regimen)
|
Rocklatan (Latanoprost +1)
n=45 Participants
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +1 medical therapy regimen)
|
Rocklatan (Latanoprost +2)
n=30 Participants
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +2 medical therapy regimen)
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
71.1 years
STANDARD_DEVIATION 10.06 • n=7 Participants
|
69.3 years
STANDARD_DEVIATION 11.60 • n=5 Participants
|
69.0 years
STANDARD_DEVIATION 10.97 • n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0 pretreatment), Week 12Population: All subjects that received at least 1 follow-up visit with a completed IOP measure and with complete data at both baseline and final visits.
IOP was measured using Goldmann applanation tonometry at the Baseline and Week 12 visits. One eye (study eye) contributed data to this analysis. A negative value indicates an improvement in IOP. No hypothesis testing was prespecified for this endpoint.
Outcome measures
| Measure |
Rocklatan (Latanoprost Mono)
n=54 Participants
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost mono medical therapy regimen)
|
Rocklatan (Latanoprost +1)
n=37 Participants
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +1 medical therapy regimen)
|
Rocklatan (Latanoprost +2)
n=25 Participants
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +2 medical therapy regimen)
|
Rocklatan Total
n=116 Participants
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Inclusive of all Latanoprost medical therapy regimens)
|
|---|---|---|---|---|
|
Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12
|
-21.2 percent change
Standard Deviation 17.46
|
-15.7 percent change
Standard Deviation 21.91
|
-16.9 percent change
Standard Deviation 17.31
|
-18.5 percent change
Standard Deviation 18.96
|
Adverse Events
Rocklatan (Latanoprost Mono)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Rocklatan (Latanoprost +1)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Rocklatan (Latanoprost +2)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rocklatan (Latanoprost Mono)
n=61 participants at risk
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost mono medical therapy regimen)
|
Rocklatan (Latanoprost +1)
n=45 participants at risk
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +1 medical therapy regimen)
|
Rocklatan (Latanoprost +2)
n=30 participants at risk
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +2 medical therapy regimen)
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/61 • Adverse events (AEs) were collected for the duration of individual participation in the study, approximately 12 weeks (±7 days).
An AE was defined as any untoward medical occurrence associated with the administration of the study intervention in humans, whether or not considered related to the study medication. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the investigator. This analysis population includes subjects who have received at least 1 dose of study medication.
|
0.00%
0/45 • Adverse events (AEs) were collected for the duration of individual participation in the study, approximately 12 weeks (±7 days).
An AE was defined as any untoward medical occurrence associated with the administration of the study intervention in humans, whether or not considered related to the study medication. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the investigator. This analysis population includes subjects who have received at least 1 dose of study medication.
|
3.3%
1/30 • Adverse events (AEs) were collected for the duration of individual participation in the study, approximately 12 weeks (±7 days).
An AE was defined as any untoward medical occurrence associated with the administration of the study intervention in humans, whether or not considered related to the study medication. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the investigator. This analysis population includes subjects who have received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Rocklatan (Latanoprost Mono)
n=61 participants at risk
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost mono medical therapy regimen)
|
Rocklatan (Latanoprost +1)
n=45 participants at risk
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +1 medical therapy regimen)
|
Rocklatan (Latanoprost +2)
n=30 participants at risk
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks (Latanoprost +2 medical therapy regimen)
|
|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
14.8%
9/61 • Adverse events (AEs) were collected for the duration of individual participation in the study, approximately 12 weeks (±7 days).
An AE was defined as any untoward medical occurrence associated with the administration of the study intervention in humans, whether or not considered related to the study medication. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the investigator. This analysis population includes subjects who have received at least 1 dose of study medication.
|
22.2%
10/45 • Adverse events (AEs) were collected for the duration of individual participation in the study, approximately 12 weeks (±7 days).
An AE was defined as any untoward medical occurrence associated with the administration of the study intervention in humans, whether or not considered related to the study medication. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the investigator. This analysis population includes subjects who have received at least 1 dose of study medication.
|
20.0%
6/30 • Adverse events (AEs) were collected for the duration of individual participation in the study, approximately 12 weeks (±7 days).
An AE was defined as any untoward medical occurrence associated with the administration of the study intervention in humans, whether or not considered related to the study medication. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the investigator. This analysis population includes subjects who have received at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER