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Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure

Sponsor
University of Miami (Other)
Overall Status
Recruiting
CT.gov ID
NCT06080438
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
19.9
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Botulinum toxin
  • Other: Saline solution
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure Height, Ocular Surface and Tearing
Actual Study Start Date :
Nov 29, 2022
Anticipated Primary Completion Date :
Jul 28, 2024
Anticipated Study Completion Date :
Jul 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Botulinum toxin group

Participants will receive botulinum toxin eyes drop and be 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

    		•
    Active Comparator: Saline solution group

    Participants will receive saline eye drops and be in this group for up to 40 minutes.

    Other: Saline solution
    1 cc of saline solution eye drops administered one time to the eye via eye drops

    Outcome Measures

    Primary Outcome Measures

    1. Change in palpebral fissure height [Baseline, day 3, 7,14 days]

      Palpebral fissure height will be calculated from the sum of marginal reflex distance 1 and 2 measured by the researcher.

    Secondary Outcome Measures

    1. Change in eye ocular surface [Baseline, day 3, 7,14 days]

      Scoring of the ocular surface will be done by fluorescein staining and evaluating with a slit lamp and grading: 0 (no punctate staining) (sparse density) (moderate density) (high density and overlapping lesions).

    2. Change in tearing [Baseline, day 3, 7,14 days]

      Scoring of tearing will be done by Schirmer I test with anesthesia. The grading would be done as follows: 0 to 5 mm of wetting, severe dry eyes; 5 to 10 mm of wetting, moderately dry eyes; 10 to 15 mm of wetting, mildly dry eyes; and greater than 15 mm of wetting, normal tear function.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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),

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Miami Miami Florida United States 33135

    Sponsors and Collaborators

    • University of Miami

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wendy Lee, Professor of Clinical, University of Miami
    ClinicalTrials.gov Identifier:
    NCT06080438
    Other Study ID Numbers:
    • 20220083
    First Posted:
    Oct 12, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Blepharospasm
    Botulinum Toxins

    Study Results

    No Results Posted as of Oct 12, 2023