Trial Outcomes & Findings for A Study of TRS01 in Participants With Post-surgical Ocular Inflammation (NCT NCT04222725)
NCT ID: NCT04222725
Last Updated: 2021-10-14
Results Overview
Number of adverse events that occurred during the study
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
37 participants
Primary outcome timeframe
14 days
Results posted on
2021-10-14
Participant Flow
Participant milestones
| Measure |
TRS01 Low Dose
TRS01 eye drops: Dosed 4 times a day (QID)
|
TRS01 Medium Dose
TRS01 eye drops: Dosed QID
|
TRS01 High Dose
TRS01 eye drops: Dosed QID
|
Placebo
Placebo eye drops: Dosed QID
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
9
|
10
|
|
Overall Study
COMPLETED
|
8
|
9
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
TRS01 Low Dose
TRS01 eye drops: Dosed 4 times a day (QID)
|
TRS01 Medium Dose
TRS01 eye drops: Dosed QID
|
TRS01 High Dose
TRS01 eye drops: Dosed QID
|
Placebo
Placebo eye drops: Dosed QID
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of TRS01 in Participants With Post-surgical Ocular Inflammation
Baseline characteristics by cohort
| Measure |
TRS01 Low Dose
n=8 Participants
TRS01 eye drops: Dosed 4 times a day (QID)
|
TRS01 Medium Dose
n=10 Participants
TRS01 eye drops: Dosed QID
|
TRS01 High Dose
n=9 Participants
TRS01 eye drops: Dosed QID
|
Placebo
n=10 Participants
Placebo eye drops: Dosed QID
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 10.11 • n=93 Participants
|
63.8 years
STANDARD_DEVIATION 7.77 • n=4 Participants
|
74.9 years
STANDARD_DEVIATION 5.84 • n=27 Participants
|
67.0 years
STANDARD_DEVIATION 7.79 • n=483 Participants
|
67.6 years
STANDARD_DEVIATION 8.74 • n=36 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
9 Participants
n=36 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
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Iris Color
Dark Brown
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
|
Iris Color
Light Brown
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Iris Color
Blue
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Iris Color
Gray
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Iris Color
Hazel
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Anterior Chamber Cell Grade in the Study Eye
2 (6-15 Cells)
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Anterior Chamber Cell Grade in the Study Eye
3 (16-30 Cells)
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
|
Anterior Chamber Cell Grade in the Study Eye
4 (>30 Cells)
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: All randomized subjects who took at least 1 dose of study drug
Number of adverse events that occurred during the study
Outcome measures
| Measure |
TRS01 Low Dose
n=8 Participants
TRS01 eye drops: Dosed 4 times a day (QID)
|
TRS01 Medium Dose
n=10 Participants
TRS01 eye drops: Dosed QID
|
TRS01 High Dose
n=9 Participants
TRS01 eye drops: Dosed QID
|
Placebo
n=10 Participants
Placebo eye drops: Dosed QID
|
|---|---|---|---|---|
|
Assessment of Both Systemic and Ocular Adverse Events
|
0 Number of TEAE
|
3 Number of TEAE
|
0 Number of TEAE
|
0 Number of TEAE
|
Adverse Events
TRS01 Low Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TRS01 Medium Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TRS01 High Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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 |
TRS01 Low Dose
n=8 participants at risk
TRS01 eye drops: Dosed 4 times a day (QID)
|
TRS01 Medium Dose
n=10 participants at risk
TRS01 eye drops: Dosed QID
|
TRS01 High Dose
n=9 participants at risk
TRS01 eye drops: Dosed QID
|
Placebo
n=10 participants at risk
Placebo eye drops: Dosed QID
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • 14 days
Safety Population: all randomized subjects who took at least 1 dose of study drug. Adverse events were collected from the signing of the Informed Consent Form (Screening) to the end of study (Day 15 or Early Termination).
|
10.0%
1/10 • Number of events 2 • 14 days
Safety Population: all randomized subjects who took at least 1 dose of study drug. Adverse events were collected from the signing of the Informed Consent Form (Screening) to the end of study (Day 15 or Early Termination).
|
0.00%
0/9 • 14 days
Safety Population: all randomized subjects who took at least 1 dose of study drug. Adverse events were collected from the signing of the Informed Consent Form (Screening) to the end of study (Day 15 or Early Termination).
|
0.00%
0/10 • 14 days
Safety Population: all randomized subjects who took at least 1 dose of study drug. Adverse events were collected from the signing of the Informed Consent Form (Screening) to the end of study (Day 15 or Early Termination).
|
|
Product Issues
Device Dislocation
|
0.00%
0/8 • 14 days
Safety Population: all randomized subjects who took at least 1 dose of study drug. Adverse events were collected from the signing of the Informed Consent Form (Screening) to the end of study (Day 15 or Early Termination).
|
10.0%
1/10 • Number of events 1 • 14 days
Safety Population: all randomized subjects who took at least 1 dose of study drug. Adverse events were collected from the signing of the Informed Consent Form (Screening) to the end of study (Day 15 or Early Termination).
|
0.00%
0/9 • 14 days
Safety Population: all randomized subjects who took at least 1 dose of study drug. Adverse events were collected from the signing of the Informed Consent Form (Screening) to the end of study (Day 15 or Early Termination).
|
0.00%
0/10 • 14 days
Safety Population: all randomized subjects who took at least 1 dose of study drug. Adverse events were collected from the signing of the Informed Consent Form (Screening) to the end of study (Day 15 or Early Termination).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between Principal Investigators (and their Institutions) and the Sponsor that restricts the PI's rights to discuss or publish results of this study without the prior written consent of the study Sponsor.
- Publication restrictions are in place
Restriction type: OTHER