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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostaglandin Analog vs Timolol | Experimental | 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. |
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| Prostaglandin Analog | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostaglandin Analog | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in appearance of facial periorbital region at 6 months. | Baseline and 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea L. Kossler, M.D. | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital and Clinics | Stanford | California | 94304 | United States |
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| D006111 | Graves Disease |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
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| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D000069580 | Bimatoprost |
| D000069557 | Travoprost |
| C485333 | tafluprost |
| D000077338 | Latanoprost |
| D013999 | Timolol |
| ID | Term |
|---|---|
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
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| Timolol | Drug | Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes. |
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| Change from baseline in appearance of facial periorbital region at 3, 6, 9 and 12 months. | Baseline and 3, 6, 9 and 12 months |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008055 |
| Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |