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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 3, 7,14 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My upper eyelid is retracted or uneven by more than 1mm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 3, 7,14 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in palpebral fissure height

Secondary outcome measures

Change in eye ocular surface

Change in tearing

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

2016

Completed Phase 4

~180

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

410,066 Total Patients Enrolled

Wendy Lee, MDPrincipal InvestigatorUniversity of Miami

2 Previous Clinical Trials

11 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned any of the Botulinum toxin varieties for clinical use?

"Given the fact that this is a Phase 4 trial, indicating approval by various regulatory bodies, our team at Power has assigned Botulinum toxin group an efficacy rating of 3."

Answered by AI

What is the target enrollment size for this trial?

"Correct. According to the data available on clinicaltrials.gov, this research study is actively seeking participation from 10 individuals and is being conducted at 1 site since its inception in November of 2022. The details have been recently updated as recently as October 6th 2023."

Answered by AI

Is enrollment available for this clinical trial?

"Clinicialtrials.gov reveals that this clinical trial is still open to recruitment, with the initial posting date being November 29th 2022 and the last update having been on October 6th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure

Wendy Lee 2022. "Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06080438.