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

May 14, 2018 updated by: Andrea L Kossler, Stanford University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • Latanoprost
  • Bimatoprost
  • Travoprost Z
  • Tafluprost
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 Names:
  • 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:
  • Latanoprost
  • Bimatoprost
  • Travoprost Z
  • Tafluprost

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Hertel exophthalmometry at 3, 6, 9 and 12 months.
Time Frame: Baseline and 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.
Time Frame: Baseline and 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.
Time Frame: Baseline and 3, 6, 9 and 12 months
Baseline and 3, 6, 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 16, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 22, 2013

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26654

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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