Anterior Uveitis
Conditions
Keywords
Iontophoresis, Ophthalmology, Non-Infectious Anterior Segment Uveitis
Brief summary
The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.
Detailed description
This will be a Phase 3, randomized, double-masked, parallel arm, positive-controlled non-inferiority study, in which up to 250 subjects (approximately 125 subjects per treatment arm) will be enrolled at up to 60 clinical sites. Patients with non-infectious anterior segment uveitis who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include BCVA, slit lamp examination, fundus exam, IOP by tonometry will be used to determine eligibility.
Interventions
40 mg/mL
DRUGPrednisolone Acetate Ophthalmic (1%)
Prednisolone Acetate (1%)
Sponsors
Eyegate Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an AC cell count of ≥ 11 cells 2. Receive, understand, and sign a copy of the written informed consent form 3. Be able to return for all study visits and willing to comply with all study-related instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with an AC cell count of zero at Day 14 | Day 14 ± 2 days |
Countries
United States
Outcome results
None listed