Trial Outcomes & Findings for Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery (NCT NCT02329743)
NCT ID: NCT02329743
Last Updated: 2019-02-20
Results Overview
score of zero for the Standardization of Uveitis Nomenclature scale
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
256 participants
Primary outcome timeframe
Day 8
Results posted on
2019-02-20
Participant Flow
Participant milestones
| Measure |
RX-10045 0.05% Nanomicellar Solution
topical eye drops
RX-10045: topical therapy
|
RX-10045 0.1% Nanomicellar Solution
topical eye drops
RX-10045: topical therapy
|
Vehicle
topical eye drops
RX-10045: topical therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
84
|
87
|
85
|
|
Overall Study
COMPLETED
|
78
|
80
|
77
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
8
|
Reasons for withdrawal
| Measure |
RX-10045 0.05% Nanomicellar Solution
topical eye drops
RX-10045: topical therapy
|
RX-10045 0.1% Nanomicellar Solution
topical eye drops
RX-10045: topical therapy
|
Vehicle
topical eye drops
RX-10045: topical therapy
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
1
|
|
Overall Study
Other
|
0
|
2
|
3
|
Baseline Characteristics
Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery
Baseline characteristics by cohort
| Measure |
RX-10045 0.05% Nanomicellar Solution
n=79 Participants
topical eye drops
RX-10045: topical therapy
|
RX-10045 0.1% Nanomicellar Solution
n=79 Participants
topical eye drops
RX-10045: topical therapy
|
Vehicle
n=78 Participants
topical eye drops
RX-10045: topical therapy
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
66.1 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
66.5 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
206 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
197 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 8Population: ITT
score of zero for the Standardization of Uveitis Nomenclature scale
Outcome measures
| Measure |
RX-10045 0.05% Nanomicellar Solution
n=79 Participants
topical eye drops
RX-10045: topical therapy
|
RX-10045 0.1% Nanomicellar Solution
n=79 Participants
topical eye drops
RX-10045: topical therapy
|
Vehicle
n=78 Participants
topical eye drops
RX-10045: topical therapy
|
|---|---|---|---|
|
Proportion of Subjects With Clearing of Anterior Inflammation
|
18 Participants
|
18 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 3Outcome measures
| Measure |
RX-10045 0.05% Nanomicellar Solution
n=79 Participants
topical eye drops
RX-10045: topical therapy
|
RX-10045 0.1% Nanomicellar Solution
n=79 Participants
topical eye drops
RX-10045: topical therapy
|
Vehicle
n=78 Participants
topical eye drops
RX-10045: topical therapy
|
|---|---|---|---|
|
Proportion of Subjects Reporting no Ocular Pain
|
25 Participants
|
21 Participants
|
33 Participants
|
Adverse Events
RX-10045 0.05% Nanomicellar Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RX-10045 0.1% Nanomicellar Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place