Back to resultsThe Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
Primary Purpose
Thyroid Eye Disease, Ocular Hypertension, Glaucoma
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prostaglandin Analog
Timolol
Sponsored by
About this trial
This is an interventional prevention trial for Thyroid Eye Disease focused on measuring Thyroid Eye Disease, Graves' Disease, Prostaglandin Analogues
Eligibility 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.
Sites / Locations
- Stanford Hospital and Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Prostaglandin Analog vs Timolol
Prostaglandin Analog
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from baseline in appearance of facial periorbital region at 6 months.
Secondary Outcome Measures
Change from baseline in Hertel exophthalmometry at 3, 6, 9 and 12 months.
Change from baseline in intraocular pressure at 3, 6, 9 and 12 months.
Change from baseline in appearance of facial periorbital region at 3, 6, 9 and 12 months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01927406
Brief Title
The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
Official Title
The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Funding source unavailable
Study Start Date
June 2014 (Anticipated)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Eye Disease, Ocular Hypertension, Glaucoma
Keywords
Thyroid Eye Disease, Graves' Disease, Prostaglandin Analogues
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prostaglandin Analog vs Timolol
Arm Type
Experimental
Arm Description
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.
Arm Title
Prostaglandin Analog
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prostaglandin Analog
Other Intervention Name(s)
Bimatoprost, Travoprost Z, Tafluprost, Latanoprost
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Timolol
Other Intervention Name(s)
Timolol maleate 0.5%
Intervention Description
Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes.
Primary Outcome Measure Information:
Title
Change from baseline in appearance of facial periorbital region at 6 months.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change from baseline in Hertel exophthalmometry at 3, 6, 9 and 12 months.
Time Frame
Baseline and 3, 6, 9 and 12 months
Title
Change from baseline in intraocular pressure at 3, 6, 9 and 12 months.
Time Frame
Baseline and 3, 6, 9 and 12 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea L. Kossler, M.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Secondary Beneficial Effects of Prostaglandin Analog Treatment in Thyroid Eye Disease Patients.
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