## Protocol Section
### Identification Module
**NCT ID:** NCT04359979

**Brief Title:** Tamsulosin for Thyroid Lid Retraction

**Official Title:** Treatment With Tamsulosin for Upper Eyelid Retraction Related to Thyroid Eye Disease.

#### Organization Study ID Info
**ID:** SHEBA-20-7022-OS-CTIL
#### Organization
**Class:** OTHER_GOV
**Full Name:** Sheba Medical Center
### Status Module
#### Completion Date
**Date:** 2023-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-06-23

**Type:** ACTUAL

**Last Update Submit Date:** 2022-06-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-05-01

**Type:** ACTUAL

**Status Verified Date:** 2022-06

#### Study First Post Date
**Date:** 2020-04-24
**Type:** ACTUAL
**Study First Submit Date:** 2020-04-21
**Study First Submit QC Date:** 2020-04-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Sheba Medical Center

#### Responsible Party

**Investigator Affiliation:** Sheba Medical Center

**Investigator Full Name:** Dr. Oded Sagiv

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Thyroid Eye Disease

- Eyelid Diseases

**Keywords:**

- eyelid retraction

- tamsulosin

- alpha receptor antagonist

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** off label use of an approved drug for new indication

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Tamsulosin

**Label:** tamsulosin treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- tamsulosin treatment

**Description:** selective alpha1 receptor antagonist

**Name:** Tamsulosin

**Other Names:**

- Omnic

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** measuring the upper margin to reflex distance (MRD1)

**Measure:** eyelid retraction

**Time Frame:** 1 week after starting tamsulosin treatment

**Description:** measuring the upper margin to reflex distance (MRD1)

**Measure:** eyelid retraction

**Time Frame:** 1 month after starting tamsulosin treatment

**Description:** measuring the upper margin to reflex distance (MRD1)

**Measure:** eyelid retraction

**Time Frame:** 3 months after starting tamsulosin treatment

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Oded.Sagiv@sheba.health.gov.il

**Name:** Oded Sagiv, MD

**Phone:** 97235302874

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tel Hashomer

**Contacts:**

***Contact 1:***

- **Email:** oded.sagiv@sheba.health.gov.il

- **Name:** Oded Sagiv, M.D.

- **Role:** CONTACT

**Country:** Israel

**Facility:** Sheba Medical Center

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Sheba Medical Center

**Name:** Oded Sagiv, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 20450248

**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.

**PMID:** 23701912

**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.

**PMID:** 10189635

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000015785

- Term: Eye Diseases, Hereditary

- ID: D000006111

- Term: Graves Disease

- ID: D000005094

- Term: Exophthalmos

- ID: D000009916

- Term: Orbital Diseases

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000006042

- Term: Goiter

- ID: D000006980

- Term: Hyperthyroidism

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M8271

- Name: Eye Diseases

- Relevance: HIGH

- As Found: Eye Disease

- ID: M16718

- Name: Thyroid Diseases

- Relevance: HIGH

- As Found: Thyroid

- ID: M26148

- Name: Graves Ophthalmopathy

- Relevance: HIGH

- As Found: Thyroid Eye Disease

- ID: M8284

- Name: Eyelid Diseases

- Relevance: HIGH

- As Found: Eyelid Diseases

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M18339

- Name: Eye Diseases, Hereditary

- Relevance: LOW

- As Found: Unknown

- ID: M9214

- Name: Graves Disease

- Relevance: LOW

- As Found: Unknown

- ID: M8237

- Name: Exophthalmos

- Relevance: LOW

- As Found: Unknown

- ID: M12845

- Name: Orbital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M9147

- Name: Goiter

- Relevance: LOW

- As Found: Unknown

- ID: M10031

- Name: Hyperthyroidism

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005128

- Term: Eye Diseases

- ID: D000049970

- Term: Graves Ophthalmopathy

- ID: D000005141

- Term: Eyelid Diseases

- ID: D000013959

- Term: Thyroid Diseases

### Intervention Browse Module - Ancestors

- ID: D000058668

- Term: Adrenergic alpha-1 Receptor Antagonists

- ID: D000000317

- Term: Adrenergic alpha-Antagonists

- ID: D000018674

- Term: Adrenergic Antagonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000064804

- Term: Urological Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Urol

- Name: Urological Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1790

- Name: Tamsulosin

- Relevance: HIGH

- As Found: Headache

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M29194

- Name: Adrenergic alpha-1 Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M3669

- Name: Adrenergic alpha-Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20755

- Name: Adrenergic Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077409

- Term: Tamsulosin

### Misc Info Module

- Version Holder: 2024-05-24
