Back to resultsTreatment of Soft Tissue Expansion in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues
Primary Purpose
Thyroid Associated Ophthalmopathies
Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
bimatoprost 0.03%
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Associated Ophthalmopathies focused on measuring TED, Prostaglandin Analogues
Eligibility Criteria
Inclusion Criteria:
- Inactive TED (Clinical Activity Score below 3)
- Significant exophthalmos or orbital fat expansion.
Exclusion Criteria:
- Previous prostaglandin analogues treatment due to glaucoma
- Known prostaglandin analogues sensitivity.
Sites / Locations
- Ophthalmology clinics, Rabin Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prostaglandin Analogues
Arm Description
The patients will receive a single daily drop of bimatoprost for six months.
Outcomes
Primary Outcome Measures
Bimatoprost effect on soft tissue amount and exophthalmos in inactive TED patients.
To document the effect of bimatoprost treatment on the amount of soft tissue and exophthalmos in inactive TED patients. The following measurements will be performed pre, post and during treatment: orbital ultrasound (measuring the eyebrow fat, retro-orbicularis oculi fat and retrobulbar fat), Hertel exophthalmometry and Marginal Reflex Distance (MRD). The external appearance would be also documented by face picture.
Secondary Outcome Measures
Number of participants with adverse events.
Determine the safety of bimatoprost treatment by estimating the probabilities of adverse outcomes. To estimate these probabilities we shall count the number of participants suffering from known side-effects of prostaglandin analogues such as increased eyelash growth and darkening of the periocular skin and iris; as well as any other side-effects observed during treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02155049
Brief Title
Treatment of Soft Tissue Expansion in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues
Official Title
Phase 3 Study of Treatment of Soft Tissue Expansion and Exophthalmos in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prostaglandin analogues eye drops are common and effective treatment for decreasing Intra-Ocular Pressure (IOP) in Glaucoma patients. A number of recently published case reports have documented periorbital fat atrophy following treatment by prostaglandin analogues. In this study the investigators want to use this side-effect of prostaglandin analogues for the treatment of orbital and periocular fat proliferation in inactive Thyroid eye disease (TED) patients, as a conservative substitute for surgical intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Associated Ophthalmopathies
Keywords
TED, Prostaglandin Analogues
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prostaglandin Analogues
Arm Type
Experimental
Arm Description
The patients will receive a single daily drop of bimatoprost for six months.
Intervention Type
Drug
Intervention Name(s)
bimatoprost 0.03%
Other Intervention Name(s)
Lumigan (Allergan, Inc, Irvine, California)
Intervention Description
The patients will receive a single daily drop of bimatoprost for six months.
Primary Outcome Measure Information:
Title
Bimatoprost effect on soft tissue amount and exophthalmos in inactive TED patients.
Description
To document the effect of bimatoprost treatment on the amount of soft tissue and exophthalmos in inactive TED patients. The following measurements will be performed pre, post and during treatment: orbital ultrasound (measuring the eyebrow fat, retro-orbicularis oculi fat and retrobulbar fat), Hertel exophthalmometry and Marginal Reflex Distance (MRD). The external appearance would be also documented by face picture.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of participants with adverse events.
Description
Determine the safety of bimatoprost treatment by estimating the probabilities of adverse outcomes. To estimate these probabilities we shall count the number of participants suffering from known side-effects of prostaglandin analogues such as increased eyelash growth and darkening of the periocular skin and iris; as well as any other side-effects observed during treatment.
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Bimatoprost effect reversibility after treatment cessation.
Description
To measure the reversibility of bimatoprost treatment on the amount of soft tissue and exophthalmos at the end of the treatment course and 3 months post cessation. We shall perform the same measurements as described in the Primary Outcome section.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inactive TED (Clinical Activity Score below 3)
Significant exophthalmos or orbital fat expansion.
Exclusion Criteria:
Previous prostaglandin analogues treatment due to glaucoma
Known prostaglandin analogues sensitivity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Eiger, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmology clinics, Rabin Medical Center
City
Petach Tikva
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Treatment of Soft Tissue Expansion in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues
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