Treatment of Soft Tissue Expansion in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues

NCT ID: NCT02155049

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Associated Ophthalmopathies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prostaglandin Analogues

The patients will receive a single daily drop of bimatoprost for six months.

Group Type EXPERIMENTAL

bimatoprost 0.03%

Intervention Type DRUG

The patients will receive a single daily drop of bimatoprost for six months.

Interventions

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bimatoprost 0.03%

The patients will receive a single daily drop of bimatoprost for six months.

Intervention Type DRUG

Other Intervention Names

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Lumigan (Allergan, Inc, Irvine, California)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maya Eiger

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maya Eiger, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

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Ophthalmology clinics, Rabin Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Thyroid eye disease

Identifier Type: REGISTRY

Identifier Source: secondary_id

TED-01

Identifier Type: -

Identifier Source: org_study_id

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