Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure

University of Miami

Status and phase: Terminated; Phase 4

Conditions: Eyelid Spasm; Tears; Excess

Treatments: Drug: Botulinum toxin

Study type: Interventional

Funder types: Other

Identifiers

NCT06080438

20220083

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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),

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Botulinum toxin group

Experimental group

Description:

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

Treatment:

Drug: Botulinum toxin