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NCT Number: NCT02155049

Treatment of Soft Tissue Expansion 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.

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Key information

Conditions

Thyroid Associated Ophthalmopathies Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ophthalmology clinics, Rabin Medical Center

Petah Tikva, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bimatoprost 0.03%

Drug

The patients will receive a single daily drop of bimatoprost for six months.

Other names: Lumigan (Allergan, Inc, Irvine, California)

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 4, 2014
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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