Dry Eye SyndromesNCT02385292

Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

A study testing Oculeve Intranasal Lacrimal Neurostimulator in people with Dry Eye Syndromes, run by Oculeve, Inc. at 2 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

The objectives of this study are: To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications To compare the goblet cell count following application between the intranasal and extranasal applications To compare fluorescein… 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?: Oculeve Intranasal Lacrimal Neurostimulator
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 2 sitesUnited States
Study dates: 31 May 2015to 31 Mar 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

Bilateral dry eyes
Capable of providing written informed consent

Who cannot join

Chronic or recurring epistaxis (nosebleeds)
Blood coagulation disorder
Uncontrolled or poorly controlled diabetes
Heart or pulmonary disease
Females who are pregnant, planning a pregnancy or nursing

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Baylor College of Medicine, Department of Ophthalmology
Houston, Texas, 77030
Grutzmacher, Lewis & Sierra
Sacramento, California, 95815

Other trials in United States

About this study

Official title: Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye

The objectives of this study are:

To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications
To compare the goblet cell count following application between the intranasal and extranasal applications
To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications

Read the detailed description

In this study, subjects will participate for three study days during up to a 44 day period, consisting of a screening examination to determine eligibility on one day and study applications on two different days. There are two applications, intranasal and extranasal. Subjects will receive both applications, in random sequence, one at each of the two application days (Visit 2 and Visit 3). The two applications consist of:

Active intranasal device application
Active extranasal device application

Conditions: Dry Eye Syndromes
Being tested: Oculeve Intranasal Lacrimal 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.

Oculeve Intranasal Lacrimal NeurostimulatorDevice
The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.

Study groups in NCT02385292
Study group	Role	What they receive
Intranasal then Extranasal Application	Experimental	Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator. Receives: Device: Oculeve Intranasal Lacrimal Neurostimulator
Extranasal then Intranasal Application	Active comparator	Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator. Receives: Device: Oculeve Intranasal Lacrimal Neurostimulator

What is being measured

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

Fluorescein Tear Clearance With Application
Measured: Day 1

Timeline

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

31 May 201531 Mar 2016

First posted11 Mar 2015 (estimated)
Study start31 May 2015
Primary completion31 Mar 2016
Study completion31 Mar 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.
Publications (1)Papers the sponsor has linked to this study.
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: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02385292
Sponsor's protocol ID: OCUN-003
Status last verified: Sep 2021
First submitted: 2 Mar 2015
Last updated: 19 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Gumus K, Schuetzle KL, Pflugfelder SC. Randomized Controlled Crossover Trial Comparing the Impact of Sham or Intranasal Tear Neurostimulation on Conjunctival Goblet Cell Degranulation. Am J Ophthalmol. 2017 May;177:159-168. doi: 10.1016/j.ajo.2017.03.002. Epub 2017 Mar 14.
PubMed 28302532

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 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye
ClinicalTrials.gov ID: NCT02385292
Acronym / sponsor ID: OCUN-003
Conditions: Dry Eye Syndromes
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Oculeve, Inc.Industry (pharma, biotech, devices)
Study start: 31 May 2015 (actual)
Primary completion: 31 Mar 2016 (actual)
Study completion: 31 Mar 2016 (actual)
First posted: 11 Mar 2015 (estimated)
Results: Posted 19 Oct 2021

Clinical summary

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

The objectives of this study are:

To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications
To compare the goblet cell count following application between the intranasal and extranasal applications
To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications

Detailed description

Active intranasal device application
Active extranasal device application

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intranasal then Extranasal Application	Experimental	Device: Oculeve Intranasal Lacrimal NeurostimulatorIntranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
Extranasal then Intranasal Application	Active comparator	Device: Oculeve Intranasal Lacrimal NeurostimulatorExtranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.

Who may qualify

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

Key inclusion criteria (2 listed)

Bilateral dry eyes
Capable of providing written informed consent

Key exclusion criteria (5 listed)

Chronic or recurring epistaxis (nosebleeds)
Blood coagulation disorder
Uncontrolled or poorly controlled diabetes
Heart or pulmonary disease
Females who are pregnant, planning a pregnancy or nursing

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
Oculeve Intranasal Lacrimal NeurostimulatorThe Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.	Device	Extranasal then Intranasal Application, Intranasal then Extranasal Application

Primary outcome

Fluorescein Tear Clearance With Application
Time frame: Day 1

Results and safety

Results posted to the registry on 19 Oct 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
Intranasal Then Extranasal Application	0	0
Extranasal Then Intranasal Application	0	0

Primary outcome: Fluorescein Tear Clearance With Application

Time frame: Day 1

Population analysed: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intranasal Application	0 of 0	0 of 0	0
Extranasal Application	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28302532Gumus K, Schuetzle KL, Pflugfelder SC. Randomized Controlled Crossover Trial Comparing the Impact of Sham or Intranasal Tear Neurostimulation on Conjunctival Goblet Cell Degranulation. Am J Ophthalmol. 2017 May;177:159-168. doi: 10.1016/j.ajo.2017.03.002. Epub 2017 Mar 14.

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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.

Richard Lewis, MD principal investigator

Grutzmacher, Lewis & Sierra

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

Questions about this trial

What is this clinical trial studying?

A study testing Oculeve Intranasal Lacrimal Neurostimulator in people with Dry Eye Syndromes, run by Oculeve, Inc. at 2 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 2 inclusion and 5 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 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 19 Oct 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?

Fluorescein Tear Clearance With Application (time frame: Day 1). 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 NCT02385292, which also lists 1 linked publication.

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 19 Oct 2021.