Anterior Uveitis
Conditions
Brief summary
This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at sites in the China in subjects with Noninfectious Anterior Uveitis
Detailed description
In this study, subjects who meet the inclusion/exclusion criteria will be randomized to receive one of the three treatments prednisolone acetate during the Screening/Baseline Visit (Day-2 to Day 1). Starting from Visit 1 (Day 1), subjects will be administered one drop of the investigational product in the study eye in following dose regimens: 6 times per day (Q2h, 2 hours apart) for 7 days; 4 times per day (QID) for 7 days；2 times per day (BID) for 7 days；once a day (QD) for 7 days. Subjects will return to clinic for study assessments on Day 3 (Visit 2), Day 7 (Visit 3), Day 14 (Visit 4), Day 21 (Visit 5) and Day 28 (Visit 6, end of study) or early withdrawal/termination visit.
Interventions
VVN461 Ophthalmic Solution, 1.0%, for up to 28 days
VVN461 Ophthalmic Solution, 0.5%, for up to 28 days
DRUGPrednisolone acetate
Prednisolone acetate, 1%, for up to 28 days
Sponsors
VivaVision Biotech, Inc
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 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-70 years at the time providing signed informed consent * At least 1 eye diagnosed with noninfectious anterior uveitis at the time of screening * Willing and able to comply with study requirements and visit schedule
Exclusion criteria
* Diagnosis of intermediate uveitis, posterior uveitis or panuveitis in either eye at the time of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACC score of ≥2 grade from baseline at Day 14 | Day 14 | Proportion of subjects with improvement in ACC score of ≥2 grade from baseline at Day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACC score of 0 | Baseline to Day 28 | Proportion of subjects with an ACC score of 0 at any visit |
Countries
China
Outcome results
None listed