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

Study Overview
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Brief Summary
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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.

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

Conditions
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Thyroid Associated Ophthalmopathies

Intervention / Treatment
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* Drug: bimatoprost 0.03%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostaglandin Analogues<br>The patients will receive a single daily drop of bimatoprost for six months. | Drug: bimatoprost 0.03%<br>* The patients will receive a single daily drop of bimatoprost for six months.<br>* Other names: Lumigan (Allergan, Inc, Irvine, California);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bimatoprost effect on soft tissue amount and exophthalmos in inactive TED patients. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TED, Prostaglandin Analogues