Trial Outcomes & Findings for RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD (NCT NCT02128113)
NCT ID: NCT02128113
Last Updated: 2025-06-03
Results Overview
Count of central corneal endothelial cells 12 weeks post cataract surgery, compared to baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
307 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-06-03
Participant Flow
Participant milestones
| Measure |
Vehicle Ophthalmic Solution
A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension
|
Omaveloxolone Opthalmic Suspension 0.5%
A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408
|
Omaveloxolone Opthalmic Suspension 1%
A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408
|
|---|---|---|---|
|
Overall Study
STARTED
|
103
|
102
|
102
|
|
Overall Study
COMPLETED
|
100
|
99
|
101
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
1
|
Reasons for withdrawal
| Measure |
Vehicle Ophthalmic Solution
A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension
|
Omaveloxolone Opthalmic Suspension 0.5%
A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408
|
Omaveloxolone Opthalmic Suspension 1%
A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Surgery cancelled
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD
Baseline characteristics by cohort
| Measure |
Vehicle Ophthalmic Solution
n=103 Participants
A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension
|
Omaveloxolone Opthalmic Suspension 0.5%
n=102 Participants
A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408
|
Omaveloxolone Opthalmic Suspension 1%
n=102 Participants
A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408
|
Total
n=307 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 8.48 • n=7 Participants
|
68.2 years
STANDARD_DEVIATION 7.44 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 7.95 • n=4 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
170 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
279 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
95 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
278 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
United States
|
103 participants
n=5 Participants
|
102 participants
n=7 Participants
|
102 participants
n=5 Participants
|
307 participants
n=4 Participants
|
|
Central corneal endothelial cell counts at screening
|
2564.4 cell/mm^2
STANDARD_DEVIATION 329.89 • n=5 Participants
|
2555.7 cell/mm^2
STANDARD_DEVIATION 342.8 • n=7 Participants
|
2589.6 cell/mm^2
STANDARD_DEVIATION 332.24 • n=5 Participants
|
2569.9 cell/mm^2
STANDARD_DEVIATION 334.22 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent-to-treat population (all randomized patients)
Count of central corneal endothelial cells 12 weeks post cataract surgery, compared to baseline
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=98 Participants
A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension
|
Omaveloxolone Opthalmic Suspension 0.5%
n=94 Participants
A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408
|
Omaveloxolone Opthalmic Suspension 1%
n=101 Participants
A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408
|
|---|---|---|---|
|
Change From Baseline in Central Corneal Endothelial Cell Counts
|
-243.4 cells/mm^2
Standard Deviation 340.58
|
-184.8 cells/mm^2
Standard Deviation 237.00
|
-260.3 cells/mm^2
Standard Deviation 304.58
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Modified intent-to-treat population (all randomized patients with no imputation for missing data)
Absence of of anterior chamber cells is defined as anterior chamber cells = 0
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=99 Participants
A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension
|
Omaveloxolone Opthalmic Suspension 0.5%
n=98 Participants
A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408
|
Omaveloxolone Opthalmic Suspension 1%
n=99 Participants
A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408
|
|---|---|---|---|
|
Percentage of Patients With Absence of Anterior Chamber Cells at 2 Weeks After Cataract Surgery
No
|
28 Participants
|
41 Participants
|
43 Participants
|
|
Percentage of Patients With Absence of Anterior Chamber Cells at 2 Weeks After Cataract Surgery
Yes
|
71 Participants
|
57 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Modified intent-to-treat population (all randomized patients with no imputation for missing data)
Absence of of anterior chamber flare is defined as anterior chamber flare = 0
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=99 Participants
A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension
|
Omaveloxolone Opthalmic Suspension 0.5%
n=98 Participants
A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408
|
Omaveloxolone Opthalmic Suspension 1%
n=99 Participants
A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408
|
|---|---|---|---|
|
Percentage of Patients With Absence of Anterior Chamber Flare at 2 Weeks After Cataract Surgery
No
|
11 Participants
|
11 Participants
|
14 Participants
|
|
Percentage of Patients With Absence of Anterior Chamber Flare at 2 Weeks After Cataract Surgery
Yes
|
88 Participants
|
87 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Modified intent-to-treat population (all randomized patients with no imputation for missing data)
Absence of of anterior chamber cells + flare is defined as anterior chamber cells + flare = 0
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=99 Participants
A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension
|
Omaveloxolone Opthalmic Suspension 0.5%
n=98 Participants
A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408
|
Omaveloxolone Opthalmic Suspension 1%
n=99 Participants
A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408
|
|---|---|---|---|
|
Percentage of Patients With Clinical Cure (Absence of Anterior Chamber Cells + Flare) at 2 Weeks After Cataract Surgery
No
|
29 Participants
|
42 Participants
|
44 Participants
|
|
Percentage of Patients With Clinical Cure (Absence of Anterior Chamber Cells + Flare) at 2 Weeks After Cataract Surgery
Yes
|
70 Participants
|
56 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Modified intent-to-treat population (all randomized patients with no imputation for missing data)
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=100 Participants
A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension
|
Omaveloxolone Opthalmic Suspension 0.5%
n=100 Participants
A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408
|
Omaveloxolone Opthalmic Suspension 1%
n=102 Participants
A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408
|
|---|---|---|---|
|
Percentage of Patients Who Were Pain Free 1 Day After Cataract Surgery
No
|
19 Participants
|
19 Participants
|
18 Participants
|
|
Percentage of Patients Who Were Pain Free 1 Day After Cataract Surgery
Yes
|
81 Participants
|
81 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Intent-to-treat population (all randomized patients)
Count of central corneal endothelial cells 6 weeks post cataract surgery, compared to baseline
Outcome measures
| Measure |
Vehicle Ophthalmic Solution
n=94 Participants
A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension
|
Omaveloxolone Opthalmic Suspension 0.5%
n=96 Participants
A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408
|
Omaveloxolone Opthalmic Suspension 1%
n=98 Participants
A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408
|
|---|---|---|---|
|
Change From Baseline in Central Corneal Endothelial Cell Counts
|
-238.2 cells/mm^2
Standard Deviation 344.73
|
-193.9 cells/mm^2
Standard Deviation 269.54
|
-242.2 cells/mm^2
Standard Deviation 291.14
|
Adverse Events
Vehicle Ophthalmic Solution
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Omaveloxolone Opthalmic Suspension 0.5%
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Omaveloxolone Opthalmic Suspension 1%
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vehicle Ophthalmic Solution
n=103 participants at risk
A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension
|
Omaveloxolone Opthalmic Suspension 0.5%
n=102 participants at risk
A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408
|
Omaveloxolone Opthalmic Suspension 1%
n=102 participants at risk
A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408
|
|---|---|---|---|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/103 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/102 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.98%
1/102 • Number of events 1 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/103 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/102 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.98%
1/102 • Number of events 1 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.97%
1/103 • Number of events 1 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/102 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/102 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.97%
1/103 • Number of events 1 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/102 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/102 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/103 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/102 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.98%
1/102 • Number of events 1 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.97%
1/103 • Number of events 1 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/102 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/102 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.97%
1/103 • Number of events 1 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/102 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/102 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/103 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/102 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.98%
1/102 • Number of events 1 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
Other adverse events
| Measure |
Vehicle Ophthalmic Solution
n=103 participants at risk
A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Vehicle Ophthalmic Solution: Opthalmic suspension manufactured to mimic RTA 408 suspension
|
Omaveloxolone Opthalmic Suspension 0.5%
n=102 participants at risk
A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408
|
Omaveloxolone Opthalmic Suspension 1%
n=102 participants at risk
A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408
|
|---|---|---|---|
|
Eye disorders
Anterior chamber inflammation
|
1.9%
2/103 • Number of events 2 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
2.9%
3/102 • Number of events 3 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
2.9%
3/102 • Number of events 3 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.97%
1/103 • Number of events 1 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
3.9%
4/102 • Number of events 4 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
4.9%
5/102 • Number of events 5 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Eye disorders
Eye inflammation
|
1.9%
2/103 • Number of events 2 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
3.9%
4/102 • Number of events 4 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
2.9%
3/102 • Number of events 3 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Eye disorders
Eye irritation
|
0.00%
0/103 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
3.9%
4/102 • Number of events 4 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
5.9%
6/102 • Number of events 6 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Eye disorders
Eye pain
|
3.9%
4/103 • Number of events 5 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
5.9%
6/102 • Number of events 6 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
3.9%
4/102 • Number of events 4 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/103 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
3.9%
4/102 • Number of events 4 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
3.9%
4/102 • Number of events 4 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Eye disorders
Lacrimation increased
|
0.97%
1/103 • Number of events 1 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
4.9%
5/102 • Number of events 5 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
8.8%
9/102 • Number of events 10 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/103 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
2.9%
3/102 • Number of events 3 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
3.9%
4/102 • Number of events 4 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Eye disorders
Ocular hypertension
|
4.9%
5/103 • Number of events 6 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
7.8%
8/102 • Number of events 9 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
4.9%
5/102 • Number of events 5 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Eye disorders
Photophobia
|
2.9%
3/103 • Number of events 3 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
2.9%
3/102 • Number of events 3 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
7.8%
8/102 • Number of events 8 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Eye disorders
Posterior capsule opacification
|
4.9%
5/103 • Number of events 5 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
8.8%
9/102 • Number of events 10 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
2.9%
3/102 • Number of events 4 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Eye disorders
Punctate keratitis
|
2.9%
3/103 • Number of events 4 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
3.9%
4/102 • Number of events 4 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
3.9%
4/102 • Number of events 5 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/103 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.00%
0/102 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
2.9%
3/102 • Number of events 3 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
|
Investigations
Intraocular pressure increased
|
6.8%
7/103 • Number of events 7 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
0.98%
1/102 • Number of events 1 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
2.9%
3/102 • Number of events 4 • 12 weeks
Investigators reported all AEs and SAEs that were observed or reported by patients from the time of first dose until the final visit, regardless of their relationship to study drug or their clinical significance.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER