Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Prednisolone Acetate (1%) Eyedrops
Prednisolone Eyedrops · 1 trial · 1 indication
Proportion of patients with ACC count of zero at Day 14
| Arm | Type | Description |
|---|---|---|
| Iontophoretic Dexamethasone Phosphate Ophthalmic Solution | EXPERIMENTAL | Dexamethasone phosphate (40 mg/mL) solution delivered by iontophoresis treatment consisting of 4.0 mA-min at 1.5 mA on Day 0 and Day 7 with accompanying placebo eyedrops (saline solution) for up to 28 days. |
| Prednisolone Acetate Ophthalmic Suspension (1%) | ACTIVE_COMPARATOR | Placebo (100 mM sodium citrate buffer solution) iontophoresis treatment consisting of 4.0 mA-min at 1.5 mA on Day 0 and Day 7 with accompanying prednisolone acetate ophthalmic suspension (1%) (positive control) eyedrops for up to 28 days. |
| Name | Type | Description |
|---|---|---|
| 40 mg/mL Dexamethasone phosphate ophthalmic solution | DRUG | Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) |
| Prednisolone Acetate (1%) Eyedrops | DRUG | Prednisolone acetate (1%) eyedrops |
| 100 mM sodium citrate buffer solution | DRUG | Transscleral iontophoresis delivery of 100 mM Sodium citrate buffer solution |
| Placebo Eyedrops | DRUG | Placebo Eyedrops |
Inclusion Criteria: * Male or female, age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an anterior chamber cell count of ≥ 11 cells * Receive, understand, and sign a copy of the written informed consent form * Be able to return for all study visits and willi...