Tamsulosin for Thyroid Lid Retraction

NCT04359979 | Unknown

• 1 other identifier: SHEBA-20-7022-OS-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Eye Disease; Eyelid Diseases

Keywords

eyelid retraction; tamsulosin; alpha receptor antagonist

Outcome Measures

Primary Outcomes (3)

• eyelid retraction

  measuring the upper margin to reflex distance (MRD1)

  1 week after starting tamsulosin treatment

• eyelid retraction

  measuring the upper margin to reflex distance (MRD1)

  1 month after starting tamsulosin treatment

• eyelid retraction

  measuring the upper margin to reflex distance (MRD1)

  3 months after starting tamsulosin treatment

Study Arms (1)

tamsulosin treatment

EXPERIMENTAL

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

Drug: Tamsulosin

Interventions

Tamsulosin DRUG

selective alpha1 receptor antagonist

Also known as: Omnic

tamsulosin treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnant/breastfeeding women
• previous eyelid surgery/trauma

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

RECRUITING

Related Publications (3)

• 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.

  PMID: 20450248 BACKGROUND

• 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.

  PMID: 23701912 BACKGROUND

• 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.

  PMID: 10189635 BACKGROUND

MeSH Terms

Conditions

Graves Ophthalmopathy; Eyelid Diseases

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Oded Sagiv, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oded Sagiv, MD

CONTACT

97235302874; Oded.Sagiv@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: off label use of an approved drug for new indication

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)