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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02517619
Other study ID # EGP-437-006
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 16, 2016
Est. completion date May 29, 2018

Study information

Verified date July 2018
Source Eyegate Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 251
Est. completion date May 29, 2018
Est. primary completion date April 20, 2018
Accepts healthy volunteers No
Gender All
Age group 12 Years to 85 Years
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:

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone Phosphate Ophthalmic Solution
40 mg/mL
Prednisolone Acetate Ophthalmic (1%)
Prednisolone Acetate (1%)

Locations

Country Name City State
United States Virginia Eye Consultants Norfolk Virginia

Sponsors (1)

Lead Sponsor Collaborator
Eyegate Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects with an AC cell count of zero at Day 14 Day 14 ± 2 days
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