Uveitis, Anterior
Conditions
Keywords
Iontophoresis, Non-Infectious Acute Anterior Segment Uveitis, Ophthalmology
Brief summary
The purpose of this study is to define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with non-infectious anterior segment uveitis.
Detailed description
This is a randomized, double-masked, parallel group, dose-comparison, exploratory study of four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients with non-infectious anterior segment uveitis. The current study will evaluate the safety, tolerability, and efficacy of this technology at the four dose levels to determine a safe effective dose appropriate for future trials.
Interventions
DRUGEGP-437 1.6 mA-min at 0.4 with EyeGate® II System
Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System
DRUGEGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System
Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System
DRUGEGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System
Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System
DRUGEGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System
Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System
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
• Non-infectious anterior uveitis
Exclusion criteria
* Uveitis of infectious etiology * Previous anterior uveitis episode ≤ 4 weeks prior to baseline * Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications * Topical corticosteroid treatment in either eye \< 48 hours prior to baseline * Oral corticosteroid or intraorbital corticosteroid treatment in either eye \< 2 weeks prior to baseline * Active intermediate or posterior uveitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with an ACC score of zero at Days 14 and 28 | Prospective study, subjects followed for 28 days | Proportion of subjects with an anterior chamber cell (ACC) score of zero at Days 14 and 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to ACC score of zero | Prospective study, subjects followed for 28 days | Time to anterior chamber cell score of zero |
| Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28 | Prospective study, subjects followed for 28 days | Proportion of subjects with a reduction of one full anterior chamber cell score or more (≥ 0.5 decrease) from baseline at Day 28 |
| Change from baseline in ACC score at Day 28 | Prospective study, subjects followed for 28 days | Change from baseline in anterior chamber cell score at Day 28 |
| Treatment emergent adverse events | Prospective study, subjects followed for 28 days | Treatment emergent adverse events |
Countries
India, United States
Outcome results
None listed