Dry Eye SyndromeNCT02798289

Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

A study testing Oculeve Intranasal Neurostimulator in people with Dry Eye Syndrome and Keratoconjunctivitis Sicca, 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 primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) 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 Syndrome, Keratoconjunctivitis Sicca
What is being tested?: Oculeve Intranasal Neurostimulator
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 2 sitesUnited States
Study dates: Jun 2016to Aug 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

Subjects with dry eye disease
Literate, able to speak English or Spanish, and able to complete questionnaires independently
Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

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
Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
Corneal transplant in either or both eyes
Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Sall Research Medical Center
Artesia, California, 90701
Aesthetic Eyecare Institute
Newport Beach, California, 92663

Other trials in United States

About this study

Official title: A Single Arm, Multicenter, Open-Label Study Designed to Evaluate Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

Read the detailed description

This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.

Conditions: Dry Eye Syndrome, Keratoconjunctivitis Sicca
Being tested: Oculeve Intranasal Neurostimulator
Medical subject headings: Dry Eye Syndromes, Keratoconjunctivitis Sicca

What participants receive

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

Oculeve Intranasal NeurostimulatorDevice
Neurostimulation device

Study groups in NCT02798289
Study group	Role	What they receive
Active - Device	Experimental	The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment. Receives: Device: Oculeve Intranasal Neurostimulator

What is being measured

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

Tear Meniscus Height Captured by Optical Coherence Tomography
Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.
Measured: Day 1

Timeline

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

Jun 2016Aug 2016

First posted14 Jun 2016 (estimated)
Study startJun 2016
Primary completionAug 2016
Study completionAug 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 SyndromeStudies 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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02798289
Sponsor's protocol ID: OCUN-014
Status last verified: Sep 2017
First submitted: 9 Jun 2016
Last updated: 25 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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 Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Arm, Multicenter, Open-Label Study Designed to Evaluate Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
ClinicalTrials.gov ID: NCT02798289
Acronym / sponsor ID: OCUN-014
Conditions: Dry Eye Syndrome, Keratoconjunctivitis Sicca
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Oculeve, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 14 Jun 2016 (estimated)
Results: Posted 25 Oct 2017

Clinical summary

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

Detailed description

This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Active - Device	Experimental	Device: Oculeve Intranasal NeurostimulatorThe Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment.

Who may qualify

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

Key inclusion criteria (3 listed)

Subjects with dry eye disease
Literate, able to speak English or Spanish, and able to complete questionnaires independently
Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

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
Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
Corneal transplant in either or both eyes
Participation in any clinical trial with a new active substance or a new device within 30 days of 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
Oculeve Intranasal NeurostimulatorNeurostimulation device	Device	Active - Device

Primary outcome

Tear Meniscus Height Captured by Optical Coherence Tomography
Time frame: Day 1
Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.

Results and safety

Results posted to the registry on 25 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active - Device	55	55

Primary outcome: Tear Meniscus Height Captured by Optical Coherence Tomography

Time frame: Day 1. Mean (Standard Deviation). Unit: µm

Measure	Active - Device n = 55
Pre-stimulation TMH	238.4 (16.7)
Post-stimulation TMH	634.9 (60.8)

Population analysed: Safety population included all subjects who received device intervention.

Adverse events

Time frame: Day 0 to Day 22. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active - Device	0 of 55 (0%)	0 of 55 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dry Eye Syndrome

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Sjogren's Syndrome, Sjögren
RecruitingPhase 1
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Not yet recruitingPhase 2
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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.

Neil Friedman, MD study director

Mid-Peninsula Ophthalmology Medical Group

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 Neurostimulator in people with Dry Eye Syndrome and Keratoconjunctivitis Sicca, 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 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 25 Oct 2017. 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 25 Oct 2017). 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?

Tear Meniscus Height Captured by Optical Coherence Tomography (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 NCT02798289.

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 25 Oct 2017.