Dry Eye SyndromesNCT03827564

Goblet Cell Degranulation Produced by Intranasal Tear Neurostimulator (ITN) in Dry Eye Disease

A study testing Intranasal Tear Neurostimulator (ITN) [TrueTear®] in people with Dry Eye Syndromes, run by Allergan at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate goblet cell degranulation following acute use of the Intranasal Tear Neurostimulator in participants with dry eye. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Dry Eye Syndromes
What is being tested?: Intranasal Tear Neurostimulator (ITN) [TrueTear®]
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 24 Jun 2019to 8 Jun 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Capable of giving verbal and signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Have not worn contact lenses for at least 7 days prior to the screening visit and are willing to forego the use of contact lenses for the duration of the study
The participant should be literate, able to speak English, and able to complete questionnaires independently

Who cannot join

Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
Corneal transplant in either or both eyes
Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
Women who are pregnant, planning a pregnancy, or nursing throughout the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Baylor College of Medicine - Department of Ophthalmology
Houston, Texas, 77030-3411

Other trials in United States

About this study

Official title: Goblet Cell Degranulation Produced by Nasal Neurostimulation: A Randomized, Controlled Study in Patients With Dry Eye Disease

The purpose of this study is to evaluate goblet cell degranulation following acute use of the Intranasal Tear Neurostimulator in participants with dry eye.

Conditions: Dry Eye Syndromes
Being tested: Intranasal Tear Neurostimulator (ITN) [TrueTear®]
Keywords: Dry Eye Disease
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intranasal Tear Neurostimulator (ITN) [TrueTear®]Device
The ITN applies a small electrical current to the nasal cavities to gently activate the body's natural tear production system.

Study groups in NCT03827564
Study group	Role	What they receive
ITN [TrueTear®] - Intranasal Application	Experimental	Intranasal application of the ITN. Single application at application visit. Receives: Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]
ITN [TrueTear®] - Extranasal Application	Experimental	Extranasal application of the ITN. Single application at application visit. Receives: Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in Ratio of Degranulated Goblet Cells.
Mean change from Screening to Application Visit in ratio of goblet cell degranulation post-intranasal use of the Intranasal Tear Neurostimulator (ITN) at the Application visit compared to without use of the ITN at the Screening visit
Measured: Screening (Day -60 to Day -30) to Application Visit (Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 20198 Jun 2020

First posted1 Feb 2019
Study start24 Jun 2019
Primary completion8 Jun 2020
Study completion8 Jun 2020

Why it stopped: Study discontinued due to business reasons.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye SyndromesStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03827564
Sponsor's protocol ID: 1919-802-019
Status last verified: Jul 2021
First submitted: 31 Jan 2019
Last updated: 16 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Goblet Cell Degranulation Produced by Nasal Neurostimulation: A Randomized, Controlled Study in Patients With Dry Eye Disease
ClinicalTrials.gov ID: NCT03827564
Acronym / sponsor ID: 1919-802-019
Conditions: Dry Eye Syndromes
Keywords: Dry Eye Disease
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study discontinued due to business reasons.
Enrolment: 14 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 24 Jun 2019 (actual)
Primary completion: 8 Jun 2020 (actual)
Study completion: 8 Jun 2020 (actual)
First posted: 1 Feb 2019 (actual)
Results: Posted 16 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate goblet cell degranulation following acute use of the Intranasal Tear Neurostimulator in participants with dry eye.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ITN [TrueTear®] - Intranasal Application	Experimental	Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]Intranasal application of the ITN. Single application at application visit.
ITN [TrueTear®] - Extranasal Application	Experimental	Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]Extranasal application of the ITN. Single application at application visit.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Capable of giving verbal and signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Have not worn contact lenses for at least 7 days prior to the screening visit and are willing to forego the use of contact lenses for the duration of the study
The participant should be literate, able to speak English, and able to complete questionnaires independently

Key exclusion criteria (6 listed)

Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
Corneal transplant in either or both eyes
Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study

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
Intranasal Tear Neurostimulator (ITN) [TrueTear®]The ITN applies a small electrical current to the nasal cavities to gently activate the body's natural tear production system.	Device	ITN [TrueTear®] - Extranasal Application, ITN [TrueTear®] - Intranasal Application

Primary outcome

Difference in Ratio of Degranulated Goblet Cells.
Time frame: Screening (Day -60 to Day -30) to Application Visit (Day 0)
Mean change from Screening to Application Visit in ratio of goblet cell degranulation post-intranasal use of the Intranasal Tear Neurostimulator (ITN) at the Application visit compared to without use of the ITN at the Screening visit

Results and safety

Results posted to the registry on 16 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ITN [TrueTear®] - Intranasal Application	9	8
ITN [TrueTear®] - Extranasal Application	5	5

Primary outcome: Difference in Ratio of Degranulated Goblet Cells.

Time frame: Screening (Day -60 to Day -30) to Application Visit (Day 0). Mean (Standard Deviation). Unit: Ratio

Measure	ITN [TrueTear®] - Intranasal Application n = 6	ITN [TrueTear®] - Extranasal Application n = 5
Value	0.007 (0.171)	0.124 (0.069)

Population analysed: Of the 14 Randomized participants, 13 received a single application of the Intranasal Tear Neurostimulator (ITN)

Adverse events

Time frame: Adverse data was collected from participants at Screening (Day -60 to Day -30) to the Application Visit (Day 0), with a 30-day safety follow-up after the application. A period of 60 to 90 days in total.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ITN [TrueTear®] - Intranasal Application	0 of 9 (0%)	0 of 9 (0%)	0 of 9
ITN [TrueTear®] - Extranasal Application	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Limitations and caveats (from the sponsor): This study was terminated early, resulting in a small number of patients analyzed. Only a descriptive statistical analysis will be performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.

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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.

Stephen Pflugfelder, MD principal investigator

Baylor College of Medicine, Department of Ophthalmology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intranasal Tear Neurostimulator (ITN) [TrueTear®] in people with Dry Eye Syndromes, run by Allergan 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 16 Aug 2021. 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?

Yes. Results are posted in the registry (first posted 16 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Difference in Ratio of Degranulated Goblet Cells. (time frame: Screening (Day -60 to Day -30) to Application Visit (Day 0)). 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 NCT03827564.

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 16 Aug 2021.