Dry Eye SyndromesNCT02910713

Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation

A study testing Intranasal Tear Neurostimulator in people with Dry Eye Syndromes, run by Allergan at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally (active) compared with the same device applied extranasally (control) relating to symptoms of dry eye exacerbated by the Controlled Adverse Environment model. 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
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 185 participants
Where: 3 sitesUnited States
Study dates: 30 Sep 2016to 31 Oct 2016
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

Moderate to severe dry eye disease
Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
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 risk of clinically significant increased bleeding
Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
Corneal transplant in either or both eyes
A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit
Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Eye Care Institute
Louisville, Kentucky, 40206
Total Eye Care, PA
Memphis, Tennessee, 38119
Nashville Vision Associates
Nashville, Tennessee, 37205

Other trials in United States

About this study

Official title: Multicenter, Randomized, Controlled, Single-Masked, Cross-Over Clinical Trial to Evaluate Dry Eye Symptoms With Application of the Oculeve Intranasal Tear Neurostimulator During Exposure to a Controlled Adverse Environment (CAE®)

Read the detailed description

Participants will be randomized to a single application sequence, either sequence "A" (intranasal application followed by control application) or sequence "B" (control application followed by intranasal application) using the device. Upon entering the CAE, participants will complete dry eye questionnaires every five minutes and will administer the device either intranasally or extranasally in randomized sequence when a certain level of ocular discomfort has been reached.

Conditions: Dry Eye Syndromes
Being tested: Intranasal Tear Neurostimulator
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 NeurostimulatorDevice
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Study groups in NCT02910713
Study group	Role	What they receive
Intranasal Application	Experimental	Intranasal Tear Neurostimulator applied intranasally device (active), intranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure. Receives: Device: Intranasal Tear Neurostimulator
Extranasal Application	Sham comparator	Intranasal Tear Neurostimulator device applied extranasally (control) for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure. Receives: Device: Intranasal Tear Neurostimulator

What is being measured

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

Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS)
The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to "no dryness" and 100 corresponds to "maximal dryness". A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.
Measured: Pre-application to Post-application on Day 0

Secondary outcomes (1)

Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score
The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the eye that reached the threshold triggering the first application or if both eyes reach the threshold at the same time, the eye with the higher discomfort score or if both eyes are the same, the right eye was used. A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.
Measured: Pre-application to Post-application on Day 0

Timeline

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

30 Sep 201631 Oct 2016

First posted22 Sep 2016 (estimated)
Study start30 Sep 2016
Primary completion31 Oct 2016
Study completion31 Oct 2016

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02910713
Sponsor's protocol ID: OCUN-011
Status last verified: Jan 2020
First submitted: 20 Sep 2016
Last updated: 31 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: Yes
Individual data sharing: No

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?

See locations

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All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Randomized, Controlled, Single-Masked, Cross-Over Clinical Trial to Evaluate Dry Eye Symptoms With Application of the Oculeve Intranasal Tear Neurostimulator During Exposure to a Controlled Adverse Environment (CAE®)
ClinicalTrials.gov ID: NCT02910713
Acronym / sponsor ID: OCUN-011
Conditions: Dry Eye Syndromes
Study type: Interventional
Recruitment status: Completed
Enrolment: 185 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 30 Sep 2016 (actual)
Primary completion: 31 Oct 2016 (actual)
Study completion: 31 Oct 2016 (actual)
First posted: 22 Sep 2016 (estimated)
Results: Posted 31 Jan 2020

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Intranasal Application	Experimental	Device: Intranasal Tear NeurostimulatorIntranasal Tear Neurostimulator applied intranasally device (active), intranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.
Extranasal Application	Sham comparator	Device: Intranasal Tear NeurostimulatorIntranasal Tear Neurostimulator device applied extranasally (control) for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.

Who may qualify

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

Key inclusion criteria (3 listed)

Moderate to severe dry eye disease
Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
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 risk of clinically significant increased bleeding
Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
Corneal transplant in either or both eyes
A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit

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 NeurostimulatorThe device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.	Device	Extranasal Application, Intranasal Application

Primary outcome

Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS)
Time frame: Pre-application to Post-application on Day 0
The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to "no dryness" and 100 corresponds to "maximal dryness". A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.

1 secondary outcome

Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score
Time frame: Pre-application to Post-application on Day 0

Results and safety

Results posted to the registry on 31 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	185	143

Primary outcome: Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS)

Time frame: Pre-application to Post-application on Day 0. Least squares mean (Standard Error). Unit: score on a scale

Measure	Intranasal Application n = 143	Extranasal Application n = 143
Value	-16.48 (1.692)	-3.12 (1.692)

Intranasal Application vs Extranasal Application: Least Squares Mean Difference: -13.36 (95% CI -17.31 to -9.40), p <0.0001, ANOVA

Population analysed: Participants from the Full Analysis Set (FAS) Population, all randomized participants who initiated a study application, who received both intranasal and extranasal applications.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 0. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 171 (0%)	0 of 171 (0%)	0 of 171

Limitations and caveats (from the sponsor): Intranasal and Extranasal data for this crossover study are combined because there is only access to combined arm data for this study. The study was acquired from another organization and limited results data are available.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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RecruitingPhase 1
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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.

Michelle Senchyna study chair

Allergan

3 sites 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 in people with Dry Eye Syndromes, run by Allergan at 3 sites 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: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 31 Jan 2020). 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?

Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS) (time frame: Pre-application to Post-application on 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 NCT02910713.

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 31 Jan 2020.