Non-infectious Anterior Uveitis
Conditions
Brief summary
The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis .
Interventions
DRUGTRS01 eye drops
Dosed four times a day (QID)
Sponsors
Tarsier Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study. * Diagnosed with active non-infectious anterior uveitis requiring an increase or initiation of topical steroids for management of ocular inflammation. An eligible subject must have: * Non-infectious active anterior uveitis with anterior chamber cells Grade 2 or Grade 3, as specified per protocol. * Must have vision ≥ 20/40 in the non-study eye. * Use adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol.
Exclusion criteria
* Any form of infectious uveitis * Active retinitis * Cancer or melanoma that is actively treated with immunotherapy * Pregnancy / lactation * Receiving specific medication/interventions as specified per protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Both Systemic and Ocular Adverse Events | 10 weeks | Number of patients experiencing Adverse Events during the study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TRS01 Low Dose TRS01 eye drops: Dosed four times a day (QID) | 8 |
| TRS01 High Dose TRS01 eye drops: Dosed four times a day (QID) | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | TRS01 High Dose | TRS01 Low Dose | Total |
|---|---|---|---|
| Age, Continuous | 56.0 years STANDARD_DEVIATION 12.45 | 49.3 years STANDARD_DEVIATION 13.44 | 52.6 years STANDARD_DEVIATION 12.98 |
| Anterior Chamber Cell Grade in the study eye 2 | 2 Participants | 6 Participants | 8 Participants |
| Anterior Chamber Cell Grade in the study eye 3 | 6 Participants | 2 Participants | 8 Participants |
| Disease course Acute | 2 Participants | 3 Participants | 5 Participants |
| Disease course Acute on Chronic | 3 Participants | 4 Participants | 7 Participants |
| Disease course Chronic | 3 Participants | 1 Participants | 4 Participants |
| Iris color Blue | 1 Participants | 0 Participants | 1 Participants |
| Iris color Dark brown | 2 Participants | 4 Participants | 6 Participants |
| Iris color Green | 1 Participants | 1 Participants | 2 Participants |
| Iris color Hazel | 1 Participants | 3 Participants | 4 Participants |
| Iris color Light brown | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 2 / 8 | 5 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Assessment of Both Systemic and Ocular Adverse Events
Number of patients experiencing Adverse Events during the study
Time frame: 10 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TRS01 Low Dose | Assessment of Both Systemic and Ocular Adverse Events | 2 Participants |
| TRS01 High Dose | Assessment of Both Systemic and Ocular Adverse Events | 5 Participants |