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Botulinum Toxin Eyedrops for Blepharospasm

Phase 4
Recruiting
Led By Wendy Lee, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of upper eyelid retraction or asymmetry (>1mm)
Be older than 18 years old
Must not have
Adults unable to consent
Inability to sit comfortably for 15 - 30 minutes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 3, 7,14 days
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial tests if applying Botulinum Toxin to the eye can reduce reflexive tearing and make eyelids appear less open.

Who is the study for?
This trial is for adults over 18 with eyelid retraction or asymmetry who can consent to participate. It's not for breastfeeding or pregnant women, prisoners, those under 18, people with known sensitivities to the medication, abnormal eyelids, certain muscle disorders like myasthenia gravis or Parkinson's disease, active eye infections, tear production issues like Sjogren's syndrome.
What is being tested?
The study tests if Botulinum Toxin eyedrops can lower the upper eyelid and reduce reflexive tearing compared to saline solution. Participants will receive either the toxin or a placebo in a controlled environment.
What are the potential side effects?
Potential side effects may include irritation at the application site, dry eyes, unintended muscle relaxation affecting other parts of the face which could alter facial expressions temporarily.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My upper eyelid is retracted or uneven by more than 1mm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give consent for myself.
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I cannot sit comfortably for 15 to 30 minutes.
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I have a neuromuscular disorder like Parkinson's or myasthenia gravis.
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I am under 18 years old.
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I have noticeable issues with the edges of my eyelids.
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My eyelid position changes due to a condition like myasthenia gravis.
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I haven't taken drugs like aminoglycosides or benzodiazepines in the last month.
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I have a condition that affects my tear production, like dry eye syndrome.
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I currently have an eye infection.
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I have not had botulinum toxin injections in my eyelids in the last 3 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 3, 7,14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 3, 7,14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in palpebral fissure height
Secondary study objectives
Change in eye ocular surface
Change in tearing

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Botulinum toxin groupExperimental Treatment1 Intervention
Participants will receive botulinum toxin eyes drop and be in this group for up to 40 minutes.
Group II: Saline solution groupActive Control1 Intervention
Participants will receive saline eye drops and be in this group for up to 40 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin
2023
Completed Phase 4
~300

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
947 Previous Clinical Trials
427,695 Total Patients Enrolled
Wendy Lee, MDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
11 Total Patients Enrolled
~3 spots leftby Nov 2025
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