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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Andrea L Kossler, Stanford University
ClinicalTrials.gov Identifier:
NCT01927406
First received: August 16, 2013
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Thyroid Eye Disease
Ocular Hypertension
Glaucoma
Drug: Prostaglandin Analog
Drug: Timolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change from baseline in appearance of facial periorbital region at 12 months. [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Hertel exophthalmometry at 12 and 24 months. [ Time Frame: 0 and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in intraocular pressure at 12 and 24 months. [ Time Frame: 0 and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in appearance of facial periorbital region at 24 months. [ Time Frame: 0 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927406

Contacts
Contact: Barbara Bartlett 650-724-9259 bbartlet@stanford.edu

Locations
United States, California
Stanford Hospital and Clinics Not yet recruiting
Stanford, California, United States, 94304
Contact: Barbara Bartlett    650-724-9259    bbartlet@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Andrea L. Kossler, M.D. Stanford University
  More Information

No publications provided

Responsible Party: Andrea L Kossler, M.D., Stanford University
ClinicalTrials.gov Identifier: NCT01927406     History of Changes
Other Study ID Numbers: 26654
Study First Received: August 16, 2013
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Thyroid Eye Disease
Graves' Disease
Prostaglandin Analogues

Additional relevant MeSH terms:
Hyperthyroidism
Eye Diseases
Glaucoma
Hypertension
Ocular Hypertension
Thyroid Diseases
Graves Ophthalmopathy
Vascular Diseases
Cardiovascular Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Goiter
Autoimmune Diseases
Immune System Diseases
Timolol
Latanoprost
Travoprost
Bimatoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 26, 2014