Tamsulosin for Thyroid Lid Retraction

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04359979
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 43
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Eye Disease; Eyelid Diseases	Drug: Tamsulosin	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: off label use of an approved drug for new indicationoff label use of an approved drug for new indication
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment With Tamsulosin for Upper Eyelid Retraction Related to Thyroid Eye Disease.
• Actual Study Start Date: May 1, 2020
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tamsulosin treatment patients will receive 0.4mg/day of Tamsulosin tablet for 3 months	Drug: Tamsulosin; selective alpha1 receptor antagonist; Other Names: Omnic

Outcome Measures

Primary Outcome Measures

1. eyelid retraction [1 week after starting tamsulosin treatment]

   measuring the upper margin to reflex distance (MRD1)

2. eyelid retraction [1 month after starting tamsulosin treatment]

   measuring the upper margin to reflex distance (MRD1)

3. eyelid retraction [3 months after starting tamsulosin treatment]

   measuring the upper margin to reflex distance (MRD1)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheba Medical Center	Tel Hashomer		Israel

Sponsors and Collaborators

• Sheba Medical Center

Investigators

• Principal Investigator: Oded Sagiv, MD, Sheba Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Dr. Oded Sagiv, Principal Investigator, Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT04359979
• Other Study ID Numbers: SHEBA-20-7022-OS-CTIL
• First Posted: Apr 24, 2020
• Last Update Posted: Jun 23, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Oded Sagiv, Principal Investigator, Sheba Medical Center: eyelid retraction; tamsulosin; alpha receptor antagonist
• Additional relevant MeSH terms: Eye Diseases; Graves Ophthalmopathy; Eyelid Diseases; Thyroid Diseases; Tamsulosin

Study Results

No Results Posted as of Jun 23, 2022