Clinical Trial: Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study

Brief Summary:

This is an initial clinical trial evaluating whether different doses of iontophoresis for delivery of dexamethasone phosphate can be tolerated by eyes of patients with non-infections, non-necrotizing scleritis. A secondary goal is to get preliminary information about whether the treatment is likely to be an effective treatment for scleritis. If the results are favorable, further trials evaluating the treatment may be pursued.

Funding sources: FDA OOPD, Eyegate Pharmaceuticals, Inc.

Detailed Summary:
Sponsor: John Kempen

Current Primary Outcome: Dose-limiting toxicity [ Time Frame: 56 days ]

Original Primary Outcome: Dose-limiting toxicity [ Time Frame: 28 days ]

Current Secondary Outcome: Improvement on scleritis scale score [ Time Frame: 56 days ]

Original Secondary Outcome: Improvement on scleritis scale score [ Time Frame: 28 days ]

Information By: University of Pennsylvania

Dates:
Date Received: January 28, 2010
Date Started: January 2012
Date Completion:
Last Updated: April 20, 2016
Last Verified: April 2016