The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the potential secondary beneficial effect of prostaglandin analogues (PA) treatment in thyroid eye disease (TED) patients. This study aims to determine if PA would change the course of the orbitopathy in TED patients by altering the progression of the common features of TED, including fatty hypertrophy, proptosis, eyelid retraction and optic nerve compression. The eyes with thyroid eye disease and elevated intraocular pressure will be randomised to the PA treatment and the other eye will serve as a control eye and will be treated with Timolol.

Official Title
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The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.

Conditions
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Thyroid Eye Disease, Ocular Hypertension, Glaucoma

Intervention / Treatment
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* Drug: Prostaglandin Analog
* Drug: Timolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild or moderate to severe thyroid eye disease in one or both eyes age > 18 years informed consent intraocular pressure > 21 mmHg or glaucoma suspect or glaucoma diagnosed in one or both eyes not on current prostaglandin analog intraocular pressure lowering therapy Exclusion Criteria: sight threatening thyroid eye disease children < 18 years old patients that are not compliant with treatment or follow-up patients already on prostaglandin analog treatment patients that undergo cosmetic periocular procedures during the study will be excluded from further follow up patients that cannot tolerate prostaglandin analog treatment. patients with bilateral thyroid eye disease and elevated intraocular pressures that cannot tolerate treatment with timolol or an alternative intraocular pressure lowering medication such as trusopt, combigan, cosopt.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostaglandin Analog vs Timolol<br>In this group, with thyroid eye disease and increased intraocular pressure in both eyes, prostaglandin analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one - randomised eye. Timolol 0.5% eye drop will be administered topically in second, control eye, two times a day. | Drug: Prostaglandin Analog<br>* The first choice drug from group of Prostaglandin Analogues will be bimatoprost, if patient will suffer from any side effect of this drug another drug from this group will be administer. If patient turned out to cannot tolerate the prostaglandin analog therapy then the exclusion criteria will be met.<br>* Other names: Latanoprost;Drug: Timolol<br>* Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes.<br>* Other names: Timolol maleate 0.5%;|
| Experimental: Prostaglandin Analog<br>In this group, with thyroid eye disease and increased intraocular pressure in only one eye Prostaglandin Analog eyedrop (bimatoprost 0.01%, travoprost z 0.004%, tafluprost 0.0015% or latanoprost 0.005%) will be administered once a day, topically, into one, affected eye. | Drug: Prostaglandin Analog<br>* The first choice drug from group of Prostaglandin Analogues will be bimatoprost, if patient will suffer from any side effect of this drug another drug from this group will be administer. If patient turned out to cannot tolerate the prostaglandin analog therapy then the exclusion criteria will be met.<br>* Other names: Latanoprost;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in appearance of facial periorbital region at 6 months. |  | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Hertel exophthalmometry at 3, 6, 9 and 12 months. |  | Baseline and 3, 6, 9 and 12 months | 
| Change from baseline in intraocular pressure at 3, 6, 9 and 12 months. |  | Baseline and 3, 6, 9 and 12 months | 
| Change from baseline in appearance of facial periorbital region at 3, 6, 9 and 12 months. |  | Baseline and 3, 6, 9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid Eye Disease, Graves' Disease, Prostaglandin Analogues