Non-infectious Anterior Uveitis
Conditions
Brief summary
This is a multicenter, randomized, single-masked, active-controlled, parallel, Phase III pivotal study in China
Interventions
1 drop for study eye each time, 6 times daily (Q2h) for 7 days; 4 times daily (QID) for 7 days; 2 times daily (BID) for 7 days; 1 time daily for 7 days
DRUG1.0% prednisolone acetate
1 drop for study eye each time, 6 times daily (Q2h) for 7 days; 4 times daily (QID) for 7 days; 2 times daily (BID) for 7 days; 1 time daily for 7 days
Sponsors
VivaVision Biotech, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* At the time of signing the informed consent form (ICF), the subject must be aged 18 to 70 years (inclusive); * At screening, the affected eye is diagnosed with non-infectious anterior uveitis (acute or recurrent acute, only unilateral eye affected patients are included); * At screening, the ACC grade of the affected eye is 2+ or 3+ \[SUN criteria\]; * At screening, the ACF grade of the affected eye is ≥1 \[SUN criteria\];
Exclusion criteria
* At screening, the affected eye has an ACC grade of 4+ or hypopyon * Diagnosis of intermediate uveitis, posterior uveitis, or panuveitis in either eye at the time of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in anterior chamber cell (ACC) grade in the study eye at Day 14 | Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with ACC grade of 0 in the study eye at Day 14 | Day 14 |
Countries
China
Outcome results
None listed