Nictavi Tarsus Patch for Managing Lagophthalmos
Public ClinicalTrials.gov record NCT05183282. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Effectiveness, Safety, and Tolerability of the Nictavi Tarsus Patch in Managing Lagophthalmos in Children and Adolescents
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05183282
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 17 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 29, 2022
- Primary completion
- Jul 19, 2022
- Completion
- Nov 30, 2022
- Last update posted
- Jul 20, 2023
2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los angeles | Los Angeles | California | 90027 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05183282, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 20, 2023 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05183282 live on ClinicalTrials.gov.