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Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure

Phase 4
Terminated
Conditions
Tears; Excess
Eyelid Spasm
Interventions
Drug: Botulinum toxin
Registration Number
NCT06080438
Lead Sponsor
University of Miami
Brief Summary

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

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
2
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)
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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),
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Botulinum toxin groupBotulinum toxinThe left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes.
Primary Outcome Measures
NameTimeMethod
Change in Palpebral Fissure Heightbaseline and Day 3

Palpebral fissure on Day 3 minus palpebral fissure at baseline.

Palpebral fissure is the area between the upper and lower eyelid margins. Palpebral fissure height on eyes is measured in primary gaze position with a clear ruler held in a central vertical position between the upper and lower eyelid margin.

Secondary Outcome Measures
NameTimeMethod
Corneal Staining DensityDay 3

Scoring of the ocular surface will be done by fluorescein staining and evaluating with a slit lamp and grading scale: 0-3 0 (no punctate staining)

1. (sparse density)

2. (moderate density)

3. (high density and overlapping lesions).

Change in Tearingbaseline and Day 3

Change in tearing will be calculated as tearing on Day 3 minus tearing at baseline.

Tearing will be assessed using the Schirmer test with anesthesia. Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes.

The result can range from a minimum of 0 mm (no tearing) to a maximum of 35 mm (maximum tearing).

Trial Locations

Locations (1)

University of Miami

🇺🇸

Miami, Florida, United States

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