Trial Outcomes & Findings for A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis (NCT NCT04222712)
NCT ID: NCT04222712
Last Updated: 2023-10-05
Results Overview
Number of patients experiencing Adverse Events during the study
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
10 weeks
Results posted on
2023-10-05
Participant Flow
Participant milestones
| Measure |
TRS01 Low Dose
TRS01 eye drops: Dosed four times a day (QID)
|
TRS01 High Dose
TRS01 eye drops: Dosed four times a day (QID)
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis
Baseline characteristics by cohort
| Measure |
TRS01 Low Dose
n=8 Participants
TRS01 eye drops: Dosed four times a day (QID)
|
TRS01 High Dose
n=8 Participants
TRS01 eye drops: Dosed four times a day (QID)
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 13.44 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 12.45 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 12.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Iris color
Dark brown
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Iris color
Light brown
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Iris color
Blue
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Iris color
Green
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Iris color
Hazel
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Anterior Chamber Cell Grade in the study eye
2
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Anterior Chamber Cell Grade in the study eye
3
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Disease course
Acute
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Disease course
Acute on Chronic
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Disease course
Chronic
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksNumber of patients experiencing Adverse Events during the study
Outcome measures
| Measure |
TRS01 Low Dose
n=8 Participants
TRS01 eye drops: Dosed four times a day (QID)
|
TRS01 High Dose
n=8 Participants
TRS01 eye drops: Dosed four times a day (QID)
|
|---|---|---|
|
Assessment of Both Systemic and Ocular Adverse Events
|
2 Participants
|
5 Participants
|
Adverse Events
TRS01 Low Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TRS01 High Dose
Serious events: 0 serious events
Other events: 5 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 four times a day (QID)
|
TRS01 High Dose
n=8 participants at risk
TRS01 eye drops: Dosed four times a day (QID)
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • 10 weeks
|
12.5%
1/8 • 10 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8 • 10 weeks
|
12.5%
1/8 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • 10 weeks
|
12.5%
1/8 • 10 weeks
|
|
General disorders
Instillation site pain
|
0.00%
0/8 • 10 weeks
|
12.5%
1/8 • 10 weeks
|
|
General disorders
Fatigue
|
0.00%
0/8 • 10 weeks
|
12.5%
1/8 • 10 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • 10 weeks
|
12.5%
1/8 • 10 weeks
|
|
Eye disorders
Iritis
|
0.00%
0/8 • 10 weeks
|
12.5%
1/8 • 10 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/8 • 10 weeks
|
12.5%
1/8 • 10 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • 10 weeks
|
0.00%
0/8 • 10 weeks
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • 10 weeks
|
0.00%
0/8 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
12.5%
1/8 • 10 weeks
|
0.00%
0/8 • 10 weeks
|
|
Infections and infestations
Hordeolum
|
12.5%
1/8 • 10 weeks
|
0.00%
0/8 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • 10 weeks
|
12.5%
1/8 • 10 weeks
|
|
Infections and infestations
Syphilis
|
0.00%
0/8 • 10 weeks
|
12.5%
1/8 • 10 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/8 • 10 weeks
|
12.5%
1/8 • 10 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
12.5%
1/8 • 10 weeks
|
0.00%
0/8 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER