Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 12 - 85 |
| Updated: | 7/28/2018 |
| Start Date: | January 16, 2016 |
| End Date: | May 29, 2018 |
A Prospective, Multi-Center, Randomized, Double-Masked, Positive Controlled, Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients With Non-Infectious Anterior Segment Uveitis
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.
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.
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.
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.
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
Exclusion Criteria:
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