Nictavi Tarsus Patch for Managing Lagophthalmos

NCT05183282 | Completed FDA Device

• 1 other identifier: CHLA-21-00354
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Lagophthalmos in "eyes closed" position

  While the subject is being asked to close their eyes like they're going to sleep, the amount of lagophthalmos (the distance between the upper and lower eyelid) will be measured in millimeters. This measurement will be taken both while the subject is wearing the Tarsus Patch on the study eye and while the subject is not wearing the Tarsus Patch on the study eye. The difference in average lagophthalmos between when the Tarsus Patch is on versus off will be analyzed by paired t-test.

  This measurement is taken on day 1 during the study visit in clinic, which will take about 1 minute.

Secondary Outcomes (3)

• Interpalpebral fissure distance in upgaze

  This measurement is taken on day 1 during the study visit in clinic, which will take about 1 minute.

• Parental and subjects' subjective experience using the Tarsus Patch

  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.

• Parental report of safety while using the Tarsus Patch

  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.

Study Arms (1)

Tarsus Patch Group

EXPERIMENTAL

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.

Device: Tarsus Patch

Interventions

Tarsus Patch DEVICE

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.

Also known as: Nictavi Tarsus Patch

Tarsus Patch Group

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patient subjects:
• Between 0 and 17 years old (inclusive)
• Diagnosis of unilateral or bilateral lagophthalmos based upon an eye examination since Jan 1, 2019
• Previously recommended to use an eyelid closure method (such as using medical tape, steristrips, moisture chambers, temporary tarsorrhaphy, etc).
• English-speaking
• Able to participate in an age-appropriate manner for the eye examination
• Parent subjects:
• years or older
• English-speaking

You may not qualify if:

• Patient subjects:
• Presence of corneal abrasion or corneal ulcer on the study eye
• Active use of bandage contact lens in the study eye
• Active dermatitis affecting the eyelids
• Inability to tolerate the Tarsus Patch in clinic
• Inability for complete mechanical closure of the eyelid by any means
• Allergy to adhesive
• Parent subjects:
• Prisoners

Sponsors & Collaborators

• Angeline Nguyen: lead

Study Sites (1)

Children's Hospital Los angeles

Los Angeles, California, 90027, United States

Location

Related Publications (2)

• Latkany RL, Lock B, Speaker M. Nocturnal lagophthalmos: an overview and classification. Ocul Surf. 2006 Jan;4(1):44-53. doi: 10.1016/s1542-0124(12)70263-x.

  PMID: 16671223 BACKGROUND

• Masoudi Alavi N, Sharifitabar Z, Shaeri M, Adib Hajbaghery M. An audit of eye dryness and corneal abrasion in ICU patients in Iran. Nurs Crit Care. 2014 Mar;19(2):73-7. doi: 10.1111/nicc.12052. Epub 2013 Oct 16.

  PMID: 24131554 BACKGROUND

MeSH Terms

Conditions

Lagophthalmos

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Eyelid Diseases

Study Officials

• Angeline M Nguyen, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Clinical Ophthalmology

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 10, 2022
• Study Start: March 30, 2022
• Primary Completion: July 20, 2022
• Study Completion: December 1, 2022
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

US (1)