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

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ClinicalTrials.gov Identifier: NCT02155049
Recruitment Status : Completed
First Posted : June 4, 2014
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Maya Eiger, 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.

Condition or disease Intervention/treatment Phase
Thyroid Associated Ophthalmopathies Drug: bimatoprost 0.03% Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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 : November 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bimatoprost

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 Name: Lumigan (Allergan, Inc, Irvine, California)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155049


Locations
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Israel
Ophthalmology clinics, Rabin Medical Center
Petach Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Maya Eiger, MD Rabin Medical Center

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Responsible Party: Maya Eiger, Medical Doctor, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02155049     History of Changes
Other Study ID Numbers: TED-01
Thyroid eye disease ( Registry Identifier: Prostaglandin Analogues )
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

Keywords provided by Maya Eiger, Rabin Medical Center:
TED
Prostaglandin Analogues

Additional relevant MeSH terms:
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Eye Diseases
Eye Diseases, Hereditary
Thyroid Diseases
Graves Ophthalmopathy
Endocrine System Diseases
Graves Disease
Exophthalmos
Orbital Diseases
Genetic Diseases, Inborn
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Bimatoprost
Antihypertensive Agents