Trial Outcomes & Findings for A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma (NCT NCT05042609)
NCT ID: NCT05042609
Last Updated: 2026-05-20
Results Overview
For FDA submission: the percentage of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye. ACC=0 is complete resolution of inflammation (0 cells).
COMPLETED
PHASE3
142 participants
28 days
2026-05-20
Participant Flow
3 participants did not receive study medication and therefore were not included in "Started"
Participant milestones
| Measure |
TRS01
TRS01: TRS01 eye drops Dosed four times a day (QID)
|
Active Comparator
FDA approved steroid eye drop (masked): FDA approved steroid eye drop Dosed four times a day (QID)
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
49
|
|
Overall Study
COMPLETED
|
81
|
46
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
Baseline characteristics by cohort
| Measure |
TRS01
n=87 Participants
TRS01: TRS01 eye drops Dosed four times a day (QID)
|
Active Comparator
n=49 Participants
FDA approved steroid eye drop (masked): FDA approved steroid eye drop Dosed four times a day (QID)
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 Years
|
9 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
14 Participants
n=60 Participants
|
|
Age, Customized
18-44 Years
|
38 Participants
n=30 Participants
|
21 Participants
n=30 Participants
|
59 Participants
n=60 Participants
|
|
Age, Customized
45-75 Years
|
40 Participants
n=30 Participants
|
23 Participants
n=30 Participants
|
63 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=30 Participants
|
25 Participants
n=30 Participants
|
81 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=30 Participants
|
24 Participants
n=30 Participants
|
55 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
White
|
61 Participants
n=30 Participants
|
36 Participants
n=30 Participants
|
97 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
14 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
19 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
9 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
4 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
79 Participants
n=30 Participants
|
43 Participants
n=30 Participants
|
122 Participants
n=60 Participants
|
|
Region of Enrollment
Europe
|
8 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
14 Participants
n=60 Participants
|
|
ACC grade
ACC grade 3 (16-30 cells)
|
44 Participants
n=30 Participants
|
22 Participants
n=30 Participants
|
66 Participants
n=60 Participants
|
|
ACC grade
ACC grade 2 (6-15 cells)
|
43 Participants
n=30 Participants
|
27 Participants
n=30 Participants
|
70 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Participants with non-missing observations
For FDA submission: the percentage of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye. ACC=0 is complete resolution of inflammation (0 cells).
Outcome measures
| Measure |
TRS01
n=82 Participants
TRS01: TRS01 eye drops Dosed four times a day (QID)
|
Active Comparator
n=47 Participants
FDA approved steroid eye drop (masked): FDA approved steroid eye drop Dosed four times a day (QID)
|
|---|---|---|
|
Anterior Chamber Cell (ACC) Grade = 0 on Day 28
ACC grade = 0: No
|
44 Participants
|
15 Participants
|
|
Anterior Chamber Cell (ACC) Grade = 0 on Day 28
ACC grade = 0: Yes
|
38 Participants
|
32 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Participants with non-missing observations
For submission to European Medicines Agency (EMA) related countries: the percentage of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye. ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells.
Outcome measures
| Measure |
TRS01
n=82 Participants
TRS01: TRS01 eye drops Dosed four times a day (QID)
|
Active Comparator
n=47 Participants
FDA approved steroid eye drop (masked): FDA approved steroid eye drop Dosed four times a day (QID)
|
|---|---|---|
|
Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 28
|
52 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 28 daysChange from baseline in Anterior Chamber Cell (ACC) score (measures ocular inflammation). ACC scale range: 0-4 ACC grade 0 = No cells ACC grade 4 = Severe ACC level Change from baseline measures the mean change in ACC grade on Day 28 in the study eye
Outcome measures
| Measure |
TRS01
n=59 Participants
TRS01: TRS01 eye drops Dosed four times a day (QID)
|
Active Comparator
n=42 Participants
FDA approved steroid eye drop (masked): FDA approved steroid eye drop Dosed four times a day (QID)
|
|---|---|---|
|
Change From Baseline (Day 1) in ACC Grade on Day 28 in the Study Eye
|
-1.9 score on a scale
Standard Deviation 0.8
|
-2.2 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Participants with non-missing observations
Proportion of subjects with ACC Grade=0 on Day 21 in the study eye.
Outcome measures
| Measure |
TRS01
n=77 Participants
TRS01: TRS01 eye drops Dosed four times a day (QID)
|
Active Comparator
n=45 Participants
FDA approved steroid eye drop (masked): FDA approved steroid eye drop Dosed four times a day (QID)
|
|---|---|---|
|
Anterior Chamber Cell (ACC) Grade on Day 21
|
32 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 21 daysChange from baseline in Anterior Chamber Cell (ACC) score (measures ocular inflammation). ACC scale range: 0-4 ACC grade 0 = No cells ACC grade 4 = Severe ACC level Change from baseline measures the mean change in ACC grade on Day 21 in the study eye
Outcome measures
| Measure |
TRS01
n=58 Participants
TRS01: TRS01 eye drops Dosed four times a day (QID)
|
Active Comparator
n=41 Participants
FDA approved steroid eye drop (masked): FDA approved steroid eye drop Dosed four times a day (QID)
|
|---|---|---|
|
Change From Baseline in ACC Grade on Day 21.
|
-1.7 score on a scale
Standard Deviation 1.0
|
-2.1 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Participants with non-missing observations
Proportions of subjects with ACC Grade = 0 or 1 on Day 21 in the study eye. ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells.
Outcome measures
| Measure |
TRS01
n=77 Participants
TRS01: TRS01 eye drops Dosed four times a day (QID)
|
Active Comparator
n=45 Participants
FDA approved steroid eye drop (masked): FDA approved steroid eye drop Dosed four times a day (QID)
|
|---|---|---|
|
Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 21
|
50 Participants
|
40 Participants
|
Adverse Events
TRS01
Active Comparator
Serious adverse events
| Measure |
TRS01
n=90 participants at risk
TRS01: TRS01 eye drops Dosed four times a day (QID)
|
Active Comparator
n=49 participants at risk
FDA approved steroid eye drop (masked): FDA approved steroid eye drop Dosed four times a day (QID)
|
|---|---|---|
|
Nervous system disorders
Optic neuritis
|
1.1%
1/90 • Number of events 1 • 6 weeks
|
0.00%
0/49 • 6 weeks
|
|
Metabolism and nutrition disorders
Hospitalization Secondary to Diabetic Ketoacidosis and COVID-19
|
1.1%
1/90 • Number of events 1 • 6 weeks
|
0.00%
0/49 • 6 weeks
|
Other adverse events
| Measure |
TRS01
n=90 participants at risk
TRS01: TRS01 eye drops Dosed four times a day (QID)
|
Active Comparator
n=49 participants at risk
FDA approved steroid eye drop (masked): FDA approved steroid eye drop Dosed four times a day (QID)
|
|---|---|---|
|
Investigations
Intra ocular pressure increased
|
1.1%
1/90 • 6 weeks
|
6.1%
3/49 • 6 weeks
|
|
Nervous system disorders
Headache
|
6.7%
6/90 • 6 weeks
|
10.2%
5/49 • 6 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/90 • 6 weeks
|
6.1%
3/49 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place