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

NCT01927406 | Withdrawn Phase 4

• 1 other identifier: 26654
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Eye Disease; Ocular Hypertension; Glaucoma

Keywords

Thyroid Eye Disease; Graves' Disease; Prostaglandin Analogues

Outcome Measures

Primary Outcomes (1)

• Change from baseline in appearance of facial periorbital region at 6 months.

  Baseline and 6 months

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Drug: Prostaglandin Analog; Drug: Timolol

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.

Drug: Prostaglandin Analog

Interventions

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.

Also known as: Bimatoprost, Travoprost Z, Tafluprost, Latanoprost

Prostaglandin Analog; Prostaglandin Analog vs Timolol

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.

Also known as: Timolol maleate 0.5%

Prostaglandin Analog vs Timolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Graves Ophthalmopathy; Ocular Hypertension; Glaucoma; Graves Disease

Interventions

Prostaglandins, Synthetic; Bimatoprost; Travoprost; tafluprost; Latanoprost; Timolol

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Andrea L. Kossler, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 22, 2013
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

US (1)