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

Phase 3

Completed

• Conditions: Thyroid Associated Ophthalmopathies
• Interventions: Drug: bimatoprost 0.03%

• Registration Number: NCT02155049
• Lead Sponsor: Rabin Medical Center

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-04
• Study Start: 2014-11
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Inactive TED (Clinical Activity Score below 3)
• Significant exophthalmos or orbital fat expansion.

Exclusion Criteria

• Previous prostaglandin analogues treatment due to glaucoma
• Known prostaglandin analogues sensitivity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostaglandin Analogues	bimatoprost 0.03%	The patients will receive a single daily drop of bimatoprost for six months.

Primary Outcome Measures

Name	Time	Method
Bimatoprost effect on soft tissue amount and exophthalmos in inactive TED patients.	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events.	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.

Trial Locations

Locations (1)

Ophthalmology clinics, Rabin Medical Center; 🇮🇱 Petach Tikva, Israel