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Tarsus Patch Group for Lagophthalmos

N/A
Waitlist Available
Led By Angeline M Nguyen, MD
Research Sponsored by Angeline Nguyen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the parental survey will be administered by phone on day 4, which is after the last day the subject wears the tarsus patch at home. the survey should take about 3 minutes per person.
Awards & highlights

Study Summary

Lagophthalmos is the inability to completely close the eyelids, which can be caused by conditions such as facial nerve dysfunction and eyelid scarring. Lagophthalmos causes evaporation of the tears, which in turn can lead to damage to the eye and permanent vision loss. Surgical interventions such as tarsorrhaphy or gold/platinum weight implantation can improve lagophthalmos, but these are invasive procedures that are not easily reversible. Temporary methods for treating lagophthalmos are also available, such as the use of medical tape or commercial eyelid closure devices. In the investigators' clinical experience, however, these methods are not well-tolerated by patients due to discomfort, especially due to the device sticking to the eyelashes. As a result, patients are at greater risk of non-compliance and subsequently experiencing ocular complications. The Nictavi Tarsus Patch is a new medical device that uses a flexible material that conforms to the upper eyelid curvature while maintaining sufficient rigidity to keep the upper eyelid in a closed position. It also is designed to be placed above the eyelash line, which allows for enhanced comfort. There has been no study to date evaluating the Tarsus Patch for its effectiveness, safety, or tolerability. The purpose of this study is to determine the effectiveness, safety, and tolerability of the Tarsus Patch in managing lagophthalmos in children and adolescents overnight. The investigators hypothesize that there will be a significant improvement in eyelid closure when using the Tarsus Patch when compared to not using any device and that over 90% of subjects will achieve complete eyelid closure with its use. The investigators also hypothesize there will be no complications related to the use of the Tarsus Patch, and that it will be considered by patients and parents to be comfortable, easy to use, and, overall, preferable to other available methods of nocturnal eyelid closure.

Eligible Conditions
  • Lagophthalmos

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~these surveys will be administered by phone on day 4, which is after the last day the subject wears the tarsus patch at home. the survey should take about 3 minutes per person.
This trial's timeline: 3 weeks for screening, Varies for treatment, and these surveys will be administered by phone on day 4, which is after the last day the subject wears the tarsus patch at home. the survey should take about 3 minutes per person. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lagophthalmos in "eyes closed" position
Secondary outcome measures
Interpalpebral fissure distance in upgaze
Parental and subjects' subjective experience using the Tarsus Patch
Parental report of safety while using the Tarsus Patch

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tarsus Patch GroupExperimental Treatment1 Intervention
All subjects will receive the Tarsus Patch to be worn and evaluated by the investigator in the clinic and to also be worn at home for 3 nights.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tarsus Patch
2022
N/A
~20

Find a Location

Who is running the clinical trial?

Angeline NguyenLead Sponsor
Angeline M Nguyen, MDPrincipal InvestigatorChildren's Hospital Los Angeles

Frequently Asked Questions

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~7 spots leftby Apr 2025