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Nictavi Tarsus Patch for Managing Lagophthalmos

NCT05183282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-07-21

No results posted yet for this 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.

Conditions

  • Lagophthalmos

Interventions

DEVICE

Tarsus Patch

The Tarsus Patch is a flexible adhesive device that is applied to the closed upper eyelid and conforms to the curvature of the eyelid to help keep the eyelid in a closed position.

Sponsors & Collaborators

  • Angeline Nguyen

    lead OTHER

Principal Investigators

  • Angeline M Nguyen, MD · Children's Hospital Los Angeles

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2022-07-20
Completion
2022-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05183282 on ClinicalTrials.gov