LagophthalmosNCT05183282
Nictavi Tarsus Patch for Managing Lagophthalmos
A study testing Tarsus Patch in people with Lagophthalmos, run by Angeline Nguyen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Lagophthalmos
- What is being tested?
- Tarsus Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 9Show fewer
- Parent subjects:
- 18 years or older
- English-speaking
Who cannot join
- 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
Show all 9Show fewer
- Allergy to adhesive
- Parent subjects:
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los angeles
Los Angeles, California, 90027
About this study
Official title: The Effectiveness, Safety, and Tolerability of the Nictavi Tarsus Patch in Managing Lagophthalmos in Children and Adolescents
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.
Read the detailed description
The investigators plan to recruit 20 children and adolescents (ages 0 to 17 years, inclusive) from the Children's Hospital Los Angeles (CHLA) ophthalmology clinics who have lagophthalmos affecting one or both eyes and have been recommended to use medical tape or other eyelid closure device to help keep their eyelids closed. The aims are to 1) objectively measure the improvement in lagophthalmos from baseline while using the Tarsus Patch, and 2) evaluate patients' and parents' experience with survey questions related to complications, comfort, ease of use, and preference for using the about the Tarsus Patch.
PROCEDURES INVOLVED
- Study visit (Day 1 of study, 60 minute commitment):
- At the study visit, informed consent will be obtained by the study coordinator or investigator.
- Once consent is obtained, the enrolled subject then undergoes an ophthalmic history and examination, including dilated examination if deemed necessary for their usual ophthalmic care. The history will include usual questions asked at a follow-up visit about ocular health and will also include details about how often, in which eye, and with what method they close their eyelids at night.
- The examination will include standard measures of vision, ocular surface health, and eyelid position and function.
- If the subject has unilateral lagophthalmos, then the involved eye will be designated as the study eye. If the subject has bilateral lagophthalmos, then the eye with more severe lagophthalmos will be designated as the study eye.
- The parent will receive an explanation about the procedures of the study.
- The study investigator will choose which Tarsus Patch size (pediatric or adult) will fit best on the child's eyelid. With the proper size, the parent will then be shown how to properly place the Tarsus Patch on the study eye, and questions will be answered about how to properly place the patch on the eye.
- The parent will then be given the following items to take home: 6 patches (this includes a few extra patches in case they are needed), and a copy of the study consent form including email and phone number to reach the study team should they have any questions
- To minimize risk, the parent will be informed that if the subject has any discomfort with an of the study protocols, they should stop the use of the Patch call the study team to discuss how to address the issue.
- At home portion (Day 1-3 of study):
- Each night for 3 nights, the parent should place a new Tarsus Patch on the subject's study eye and then place a ½ cm strip of ophthalmic ointment or gel into the study eye. The parent should then help remove the patch the next morning and throw it away.
- Phone survey (Day 4):
- A study investigator will call the parents to have them respond to the Parent Survey over the phone in the absence of the study subject.
- If the subject is 10 years of age or older and cognitively able to answer the survey questions, then they will be asked to answer the Subject Survey over the phone with the help of the parent.
- Conditions
- Lagophthalmos
- Being tested
- Tarsus Patch
- Medical subject headings
- Lagophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tarsus PatchDevice
Also called Nictavi 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Tarsus Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
While the subject is being asked to look upwards, the interpalpebral fissure distance (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 interpalpebral fissure distance between when the Tarsus Patch is on versus off will be analyzed by paired t-test.
Measured: 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
The parent and subject (if 10 years of age or older) will be asked a series of likert-style questions that assess the comfort, ease of use, and preferability of the Tarsus Patch.
Measured: 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
Parents will be asked to report and elaborate during their survey if they felt that there were any complications or adverse effects related to using the patch.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start30 Mar 2022
- Primary completion20 Jul 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LagophthalmosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angeline Nguyen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Angeline Nguyen, Children's Hospital Los Angeles
- Investigators
- Angeline M Nguyen, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183282
- Sponsor's protocol ID
- CHLA-21-00354
- Status last verified
- Jul 2023
- First submitted
- 7 Dec 2021
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 16671223Masoudi 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.
PubMed 24131554
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness, Safety, and Tolerability of the Nictavi Tarsus Patch in Managing Lagophthalmos in Children and Adolescents
- ClinicalTrials.gov ID
- NCT05183282
- Acronym / sponsor ID
- CHLA-21-00354
- Conditions
- Lagophthalmos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Angeline NguyenUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators plan to recruit 20 children and adolescents (ages 0 to 17 years, inclusive) from the Children's Hospital Los Angeles (CHLA) ophthalmology clinics who have lagophthalmos affecting one or both eyes and have been recommended to use medical tape or other eyelid closure device to help keep their eyelids closed. The aims are to 1) objectively measure the improvement in lagophthalmos from baseline while using the Tarsus Patch, and 2) evaluate patients' and parents' experience with survey questions related to complications, comfort, ease of use, and preference for using the about the Tarsus Patch.
PROCEDURES INVOLVED
- Study visit (Day 1 of study, 60 minute commitment):
- At the study visit, informed consent will be obtained by the study coordinator or investigator.
- Once consent is obtained, the enrolled subject then undergoes an ophthalmic history and examination, including dilated examination if deemed necessary for their usual ophthalmic care. The history will include usual questions asked at a follow-up visit about ocular health and will also include details about how often, in which eye, and with what method they close their eyelids at night.
- The examination will include standard measures of vision, ocular surface health, and eyelid position and function.
- If the subject has unilateral lagophthalmos, then the involved eye will be designated as the study eye. If the subject has bilateral lagophthalmos, then the eye with more severe lagophthalmos will be designated as the study eye.
- The parent will receive an explanation about the procedures of the study.
- The study investigator will choose which Tarsus Patch size (pediatric or adult) will fit best on the child's eyelid. With the proper size, the parent will then be shown how to properly place the Tarsus Patch on the study eye, and questions will be answered about how to properly place the patch on the eye.
- The parent will then be given the following items to take home: 6 patches (this includes a few extra patches in case they are needed), and a copy of the study consent form including email and phone number to reach the study team should they have any questions
- To minimize risk, the parent will be informed that if the subject has any discomfort with an of the study protocols, they should stop the use of the Patch call the study team to discuss how to address the issue.
- At home portion (Day 1-3 of study):
- Each night for 3 nights, the parent should place a new Tarsus Patch on the subject's study eye and then place a ½ cm strip of ophthalmic ointment or gel into the study eye. The parent should then help remove the patch the next morning and throw it away.
- Phone survey (Day 4):
- A study investigator will call the parents to have them respond to the Parent Survey over the phone in the absence of the study subject.
- If the subject is 10 years of age or older and cognitively able to answer the survey questions, then they will be asked to answer the Subject Survey over the phone with the help of the parent.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tarsus Patch Group | Experimental | Device: Tarsus PatchAll 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patient subjects:
- Parent subjects:
Key exclusion criteria (9 listed)
- Patient subjects:
- Parent subjects:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tarsus PatchAlso: Nictavi Tarsus PatchThe 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. | Device | Tarsus Patch Group |
Primary outcome
Lagophthalmos in "eyes closed" position
Time frame: This measurement is taken on day 1 during the study visit in clinic, which will take about 1 minute.
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.
3 secondary outcomes
Interpalpebral fissure distance in upgaze
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Background: PubMed 16671223Latkany 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.
- Background: PubMed 24131554Masoudi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angeline M Nguyen, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tarsus Patch in people with Lagophthalmos, run by Angeline Nguyen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lagophthalmos in "eyes closed" position (time frame: This measurement is taken on day 1 during the study visit in clinic, which will take about 1 minute.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183282, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.