Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure

The Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure Height, Ocular Surface and Tearing

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.

Study Overview

• Status: Terminated
• Conditions: Tears; Excess; Eyelid Spasm
• Intervention / Treatment: Drug: Botulinum toxin

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33135
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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),

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Botulinum toxin; 15 units of botulinum toxin administered one time to the eye via eye drops; Other Names: BOTOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Palpebral Fissure Height	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.	baseline and Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Staining Density	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); (sparse density); (moderate density); (high density and overlapping lesions).	Baseline
Corneal Staining Density	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); (sparse density); (moderate density); (high density and overlapping lesions).	Day 3
Change in Tearing	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).	baseline and Day 3

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Wendy Lee, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Actual): July 28, 2024
• Study Completion (Actual): July 28, 2024

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharospasm; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: 20220083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No