Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure

NCT06080438 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 20220083
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Tears; Excess; Eyelid Spasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Corneal Staining Density

  Baseline

• Corneal Staining Density

  Day 3

• Change in Tearing

  baseline and Day 3

Study Arms (1)

Botulinum toxin group

EXPERIMENTAL

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

Interventions

Botulinum toxin DRUG

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

Also known as: BOTOX

Botulinum toxin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33135, United States

Location

MeSH Terms

Conditions

Lacerations; Blepharospasm

Interventions

Botulinum Toxins; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Wounds and Injuries; Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

For interim analysis of futility, the investigators conducted the study with BT eye drops on the first 10 patients and then evaluated the results to see if there were any significant effects. If clinically significant effects are seen, then 34 patients totally (17 in BT vs 17 in saline) are included. The study was terminated and did not continue; therefore, only the first phase of the study was conducted with only one arm (BT eye drops) with results reported for the first phase only.

Results Point of Contact

• Title: Principal investigator
• Organization: University of Miami

wlee@med.miami.edu

305-326-6434

Study Officials

• Wendy Lee, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 12, 2023
• Study Start: November 29, 2022
• Primary Completion: July 28, 2024
• Study Completion: July 28, 2024
• Last Updated: December 5, 2024
• Results First Posted: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)