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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Thyroid Eye Disease; Ocular Hypertension; Glaucoma	Drug: Prostaglandin Analog; Drug: Timolol	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
Estimated Study Start Date :	June 2014
Estimated Primary Completion Date :	December 2016
Estimated Study Completion Date :	December 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Prostaglandin Analog vs Timolol; 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; 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.; Other Names: Bimatoprost; Travoprost Z; Tafluprost; Latanoprost Drug: Timolol; Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes.; Other Name: Timolol maleate 0.5%
Experimental: Prostaglandin Analog; 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; 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.; Other Names: Bimatoprost; Travoprost Z; Tafluprost; Latanoprost

Outcome Measures

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Primary Outcome Measures :

1. Change from baseline in appearance of facial periorbital region at 6 months. [ Time Frame: Baseline and 6 months ]

Secondary Outcome Measures :

1. Change from baseline in Hertel exophthalmometry at 3, 6, 9 and 12 months. [ Time Frame: Baseline and 3, 6, 9 and 12 months ]
2. Change from baseline in intraocular pressure at 3, 6, 9 and 12 months. [ Time Frame: Baseline and 3, 6, 9 and 12 months ]
3. Change from baseline in appearance of facial periorbital region at 3, 6, 9 and 12 months. [ Time Frame: Baseline and 3, 6, 9 and 12 months ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Stanford Hospital and Clinics
Stanford, California, United States, 94304

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:	Andrea L. Kossler, M.D.	Stanford University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Andrea L Kossler, M.D., Stanford University
ClinicalTrials.gov Identifier:	NCT01927406 History of Changes
Other Study ID Numbers:	26654
First Posted:	August 22, 2013
Last Update Posted:	January 16, 2018
Last Verified:	January 2018

Keywords provided by Andrea L Kossler, Stanford University:

Thyroid Eye Disease; Graves' Disease; Prostaglandin Analogues

Additional relevant MeSH terms:

Thyroid Diseases; Ocular Hypertension; Eye Diseases; Graves Ophthalmopathy; Endocrine System Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases	Timolol; Latanoprost; Bimatoprost; Travoprost; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents