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Tamsulosin for Thyroid Lid Retraction

Primary Purpose

Thyroid Eye Disease, Eyelid Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tamsulosin
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Eye Disease focused on measuring eyelid retraction, tamsulosin, alpha receptor antagonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Thyroid eye disease patients suffering from upper eyelid retraction in one or both eyes

Exclusion Criteria:

  • pregnant/breastfeeding women
  • previous eyelid surgery/trauma

Sites / Locations

  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tamsulosin treatment

Arm Description

patients will receive 0.4mg/day of Tamsulosin tablet for 3 months

Outcomes

Primary Outcome Measures

eyelid retraction
measuring the upper margin to reflex distance (MRD1)
eyelid retraction
measuring the upper margin to reflex distance (MRD1)
eyelid retraction
measuring the upper margin to reflex distance (MRD1)

Secondary Outcome Measures

Full Information

First Posted
April 21, 2020
Last Updated
June 22, 2022
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04359979
Brief Title
Tamsulosin for Thyroid Lid Retraction
Official Title
Treatment With Tamsulosin for Upper Eyelid Retraction Related to Thyroid Eye Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the effect of using Tamsulosin for treatment of eyelid retraction as part of thyroid eye disease. The treatment will be offered to all thyroid patients suffering from eyelid retraction who are treated at the thyroid clinic in Sheba's Ophthalmology department. All patient will receive information about the drug Tamsulosin, the possible side effects, and the alternative treatment options for retraction. Patients recruited will take 0.4mg/day Tamsulosin for 3 months and will have follow-ups at 1 week, 1 month and 3 months to evaluate the retraction status.
Detailed Description
Thyroid eye disease is a common autoimmune disorder caused by antibodies directed against receptors present in the thyroid cells and extra-ocular muscles and soft tissue of the orbit. The disorder is characterised by enlargement of the extra-ocular muscles, fatty and connective tissue volume. Upper lid retraction is the most common sign of the eye disease (present in up to 92%). The causes for retraction are not fully understood. It may be related to inflammation of the Levator muscle and the Muller muscle, or related to over sympathetic activity causing overstimulation of the Muller muscle. Upper lid retraction severity can range from very light to severe, with scleral show, eye dryness and even exposure keratopathy. Additionally it can have a very significant effect on the patient's appearance (a constant surprised look). Treatments for lid retraction include aggressive lubrication and tarsorrhaphy if needed (sewing the eyelids together). The Muller is a smooth muscle which elevates the upper eyelid and is sympathetically innervated (alpha receptor). The drug Tamsulosin which is a selective alpha1 receptor antagonist is commonly used today for benign prostatic hyperplasia (relaxing the prostate muscle). In this study we would like to test using Tamsulosin for treatment of lid retraction caused by thyroid eye disease. We hypothesise that the relaxation of the Muller muscle may have a beneficial effect on the retraction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Eye Disease, Eyelid Diseases
Keywords
eyelid retraction, tamsulosin, alpha receptor antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
off label use of an approved drug for new indication
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tamsulosin treatment
Arm Type
Experimental
Arm Description
patients will receive 0.4mg/day of Tamsulosin tablet for 3 months
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Omnic
Intervention Description
selective alpha1 receptor antagonist
Primary Outcome Measure Information:
Title
eyelid retraction
Description
measuring the upper margin to reflex distance (MRD1)
Time Frame
1 week after starting tamsulosin treatment
Title
eyelid retraction
Description
measuring the upper margin to reflex distance (MRD1)
Time Frame
1 month after starting tamsulosin treatment
Title
eyelid retraction
Description
measuring the upper margin to reflex distance (MRD1)
Time Frame
3 months after starting tamsulosin treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Thyroid eye disease patients suffering from upper eyelid retraction in one or both eyes Exclusion Criteria: pregnant/breastfeeding women previous eyelid surgery/trauma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oded Sagiv, MD
Phone
97235302874
Email
Oded.Sagiv@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oded Sagiv, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oded Sagiv, M.D.
Email
oded.sagiv@sheba.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20450248
Citation
Yano S, Hirose M, Nakada T, Nakayama J, Matsuo K, Yamada M. Selective alpha 1A-adrenoceptor stimulation induces Mueller's smooth muscle contraction in an isolated canine upper eyelid preparation. Curr Eye Res. 2010 May;35(5):363-9. doi: 10.3109/02713680903518858.
Results Reference
background
PubMed Identifier
23701912
Citation
Kikuchi-Utsumi K, Ishizaka M, Matsumura N, Nakaki T. Alpha(1A)-adrenergic control of piloerection and palpebral fissure width in rats. Auton Neurosci. 2013 Dec;179(1-2):148-50. doi: 10.1016/j.autneu.2013.04.011. Epub 2013 May 20.
Results Reference
background
PubMed Identifier
10189635
Citation
Esmaeli-Gutstein B, Hewlett BR, Pashby RC, Oestreicher J, Harvey JT. Distribution of adrenergic receptor subtypes in the retractor muscles of the upper eyelid. Ophthalmic Plast Reconstr Surg. 1999 Mar;15(2):92-9. doi: 10.1097/00002341-199903000-00005.
Results Reference
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Tamsulosin for Thyroid Lid Retraction

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