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Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure

Primary Purpose

Tears; Excess, Eyelid Spasm

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin
Saline solution
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tears; Excess

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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),

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Botulinum toxin group

Saline solution group

Arm Description

Participants will receive botulinum toxin eyes drop and be in this group for up to 40 minutes.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in eye ocular surface
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).
Change in tearing
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.

Full Information

First Posted
October 5, 2023
Last Updated
October 6, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT06080438
Brief Title
Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure
Official Title
The Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure Height, Ocular Surface and Tearing
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
July 28, 2024 (Anticipated)
Study Completion Date
July 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tears; Excess, Eyelid Spasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin group
Arm Type
Experimental
Arm Description
Participants will receive botulinum toxin eyes drop and be in this group for up to 40 minutes.
Arm Title
Saline solution group
Arm Type
Active Comparator
Arm Description
Participants will receive saline eye drops and be in this group for up to 40 minutes.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin
Other Intervention Name(s)
BOTOX
Intervention Description
15 units of botulinum toxin administered one time to the eye via eye drops
Intervention Type
Other
Intervention Name(s)
Saline solution
Intervention Description
1 cc of saline solution eye drops administered one time to the eye via eye drops
Primary Outcome Measure Information:
Title
Change in palpebral fissure height
Description
Palpebral fissure height will be calculated from the sum of marginal reflex distance 1 and 2 measured by the researcher.
Time Frame
Baseline, day 3, 7,14 days
Secondary Outcome Measure Information:
Title
Change in eye ocular surface
Description
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).
Time Frame
Baseline, day 3, 7,14 days
Title
Change in tearing
Description
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.
Time Frame
Baseline, day 3, 7,14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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),
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Lee, MD
Phone
3053266434
Email
wlee@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Lee, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niloufar Bineshfar, MD
Phone
305-326-6434
Email
nxb1003@miami.edu
First Name & Middle Initial & Last Name & Degree
Wendy Lee, MD
First Name & Middle Initial & Last Name & Degree
Niloufar Bineshfar, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure

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