Clinical Trial: Treatment of Soft Tissue Expansion in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 3 Study of Treatment of Soft Tissue Expansion and Exophthalmos in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues.

Brief Summary: Prostaglandin analogues eye drops are common and effective treatment for decreasing Intra-Ocular Pressure (IOP) in Glaucoma patients. A number of recently published case reports have documented periorbital fat atrophy following treatment by prostaglandin analogues. In this study the investigators want to use this side-effect of prostaglandin analogues for the treatment of orbital and periocular fat proliferation in inactive Thyroid eye disease (TED) patients, as a conservative substitute for surgical intervention.

Detailed Summary:
Sponsor: Rabin Medical Center

Current Primary Outcome: Bimatoprost effect on soft tissue amount and exophthalmos in inactive TED patients. [ Time Frame: 6 months ]

To document the effect of bimatoprost treatment on the amount of soft tissue and exophthalmos in inactive TED patients. The following measurements will be performed pre, post and during treatment: orbital ultrasound (measuring the eyebrow fat, retro-orbicularis oculi fat and retrobulbar fat), Hertel exophthalmometry and Marginal Reflex Distance (MRD). The external appearance would be also documented by face picture.


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of participants with adverse events. [ Time Frame: 9 months ]

Determine the safety of bimatoprost treatment by estimating the probabilities of adverse outcomes. To estimate these probabilities we shall count the number of participants suffering from known side-effects of prostaglandin analogues such as increased eyelash growth and darkening of the periocular skin and iris; as well as any other side-effects observed during treatment.


Original Secondary Outcome: Same as current

Information By: Rabin Medical Center

Dates:
Date Received: May 21, 2014
Date Started: November 2014
Date Completion:
Last Updated: June 14, 2015
Last Verified: June 2015