Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure

Study Overview
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Brief Summary
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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.

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

Conditions
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Tears; Excess, Eyelid Spasm

Intervention / Treatment
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* Drug: Botulinum toxin
* Other: Saline solution


Participation Criteria
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Eligibility Criteria
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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),

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin group<br>Participants will receive botulinum toxin eyes drop and be in this group for up to 40 minutes. | Drug: Botulinum toxin<br>* 15 units of botulinum toxin administered one time to the eye via eye drops<br>* Other names: BOTOX;|
| Active Comparator: Saline solution group<br>Participants will receive saline eye drops and be in this group for up to 40 minutes. | Other: Saline solution<br>* 1 cc of saline solution eye drops administered one time to the eye via eye drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, day 3, 7,14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, day 3, 7,14 days | 
| 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. | Baseline, day 3, 7,14 days |