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

February 15, 2018 updated by: Maya Eiger, Rabin Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach Tikva, Israel
        • Ophthalmology clinics, Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prostaglandin Analogues
The patients will receive a single daily drop of bimatoprost for six months.
Drug: bimatoprost 0.03%
The patients will receive a single daily drop of bimatoprost for six months.
Other Names:
  • Lumigan (Allergan, Inc, Irvine, California)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bimatoprost effect reversibility after treatment cessation.
Time Frame: 3 months
To measure the reversibility of bimatoprost treatment on the amount of soft tissue and exophthalmos at the end of the treatment course and 3 months post cessation. We shall perform the same measurements as described in the Primary Outcome section.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 4, 2014

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TED-01
  • Thyroid eye disease (Registry Identifier: Prostaglandin Analogues)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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