Clinical Trial: Pilot Study to Determine Safety and Efficacy of Orbital Injections of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease (TED)

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

Official Title: A Single-masked, Placebo Controlled, Multi-center Pilot Study to Determine the Safety and Efficacy of Orbital Injections of a Fixed Dose of LIPO-102 in Patients With Symptomatic Exophthalmos Associate

Brief Summary: This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.

Detailed Summary:
Sponsor: Neothetics, Inc

Current Primary Outcome: Safety: physical examinations, laboratory tests, VISA activity score, AE assessments [ Time Frame: 8 weeks treatment and 1 week follow up ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction [ Time Frame: 8 weeks treatment and 1 week follow up ]

Original Secondary Outcome: Same as current

Information By: Neothetics, Inc

Dates:
Date Received: August 4, 2009
Date Started: September 2009
Date Completion:
Last Updated: March 5, 2015
Last Verified: March 2015