Non-infectious Anterior Uveitis, Uveitic Glaucoma
Conditions
Brief summary
The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma
Interventions
DRUGTRS01
TRS01 eye drops Dosed four times a day (QID)
DRUGFDA approved steroid eye drop (masked)
FDA approved steroid eye drop 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
0 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* At sites in the US: Male or female up to and including 75 years of age (including all pediatric age groups). At sites in the Europe: Male or female between 18 and 70 years of age, inclusive. * Diagnosed with active non-infectious anterior uveitis with anterior chamber cell Grade 2 (6-15 cells) or Grade 3 (16-30 cells) in the study eye that are without any treatment or with Stable Medical Therapy requiring further treatment. * Have Best Corrected Visual Acuity (BCVA) vision ≥ 65 letters in the non-study eye using Early Treatment Diabetic Retinopathy Study (ETDRS).
Exclusion criteria
* Pregnant or breastfeeding females or females. * History of or active significant ocular disease in either eye. * Uncontrolled intraocular pressure (IOP; defined as \>27mmHg) or narrow angle glaucoma in either eye and/or are at risk of angle closure with dilating. * Poor posterior view due to limitation of dilation or media opacity that limits ability to examine the posterior segment. * Cancer or melanoma that is actively treated with immunotherapy. * Certain clinically significant systemic diseases or conditions. * Receiving specific medication/interventions as specified per protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Chamber Cell (ACC) Grade = 0 on Day 28 | 28 days | 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). |
| Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 28 | 28 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Day 1) in ACC Grade on Day 28 in the Study Eye | 28 days | Change 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 |
| Anterior Chamber Cell (ACC) Grade on Day 21 | 21 days | Proportion of subjects with ACC Grade=0 on Day 21 in the study eye. |
| Change From Baseline in ACC Grade on Day 21. | 21 days | Change 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 |
| Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 21 | 21 days | 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. |
Countries
France, Germany, United States
Contacts
STUDY_DIRECTORLexitas Clinical Trials
Lexitas
Participant flow
Pre-assignment details
3 participants did not receive study medication and therefore were not included in "Started"
Baseline characteristics
| Characteristic | — |
|---|---|
| ACC grade ACC grade 2 (6-15 cells) | 70 Participants |
| ACC grade ACC grade 3 (16-30 cells) | 44 Participants |
| Age, Customized 18-44 Years | 38 Participants |
| Age, Customized <18 Years | 14 Participants |
| Age, Customized 45-75 Years | 23 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 19 Participants |
| Race/Ethnicity, Customized Unknown | 11 Participants |
| Race/Ethnicity, Customized White | 97 Participants |
| Region of Enrollment Europe | 14 Participants |
| Region of Enrollment United States | 43 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 49 |
| other Total, other adverse events | 7 / 90 | 8 / 49 |
| serious Total, serious adverse events | 2 / 90 | 0 / 49 |
Outcome results
None listed