Status:
TERMINATED
Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure
Lead Sponsor:
University of Miami
Conditions:
Tears; Excess
Eyelid Spasm
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 affec...
Eligibility Criteria
Inclusion
- 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
- 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),
Key Trial Info
Start Date :
November 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06080438
Start Date
November 29 2022
End Date
July 28 2024
Last Update
December 5 2024
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33135