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Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure

NCT ID: NCT06080438

Last Updated: 2024-12-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-29

Study Completion Date

2024-07-28

Brief Summary

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The purpose of this research study is to test if Topical (applied to the surface of the eye) Botulinum Toxin temporarily lowers the upper eyelid and makes the eyelid appear less open and thereby affects the eye surface and decreases reflexive tearing.

Detailed Description

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Conditions

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Tears; Excess Eyelid Spasm

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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Botulinum toxin group

The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes.

Group Type EXPERIMENTAL

Botulinum toxin

Intervention Type DRUG

15 units of botulinum toxin administered one time to the eye via eye drops

Interventions

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Botulinum toxin

15 units of botulinum toxin administered one time to the eye via eye drops

Intervention Type DRUG

Other Intervention Names

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BOTOX

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 and above that present to the oculoplastic and reconstructive surgery department that are able to provide informed consent to participate
* Presence of upper eyelid retraction or asymmetry( \>1mm)

Exclusion Criteria

* Adults unable to consent
* Individuals less than 18 years of age
* Prisoners
* Pregnant women. o Patients will be asked if they are pregnant by research staff before participation in the study.

Women who are breast-feeding

* Known contradictions or sensitivities to study medication
* Grossly abnormal lid margins, anatomical abnormalities
* Variable ptosis or eyelid position (e.g., myasthenia gravis, blepharospasm)
* Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
* Presence of an active ocular infection
* Inability to sit comfortably for 15 - 30 minutes
* Botulinum toxin injection in the eyelids during the past 3 weeks.
* Neuromuscular disorders (e.g., Parkinson's disease or myasthenia gravis)
* Medication use known to interfere with the effects of botulinum toxin-A within the previous 1 month (e.g., aminoglycoside or benzodiazepines),
* Previous history of hypersensitivity reactions to botulinum toxin-A
* Dysfunction of tear production or secretion (e.g., meibomian gland dysfunction or Sjogren's syndrome),
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Wendy Lee

Professor of Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wendy Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20220083

Identifier Type: -

Identifier Source: org_study_id