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

Sponsor
Rabin Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02155049
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
30
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: bimatoprost 0.03%
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 3 Study of Treatment of Soft Tissue Expansion and Exophthalmos in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues.
Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
May 1, 2017

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Other Outcome Measures

    1. Bimatoprost effect reversibility after treatment cessation. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ophthalmology clinics, Rabin Medical Center Petach Tikva Israel

    Sponsors and Collaborators

    • Rabin Medical Center

    Investigators

    • Principal Investigator: Maya Eiger, MD, Rabin Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maya Eiger, Medical Doctor, Rabin Medical Center
    ClinicalTrials.gov Identifier:
    NCT02155049
    Other Study ID Numbers:
    • TED-01
    • Thyroid eye disease
    First Posted:
    Jun 4, 2014
    Last Update Posted:
    Feb 19, 2018
    Last Verified:
    Feb 1, 2018
    Keywords provided by Maya Eiger, Medical Doctor, Rabin Medical Center
    TED
    Prostaglandin Analogues
    Additional relevant MeSH terms:
    Eye Diseases
    Graves Ophthalmopathy
    Thyroid Diseases
    Bimatoprost

    Study Results

    No Results Posted as of Feb 19, 2018