Dry Eye SyndromeNCT02680158

A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome

A study testing Oculeve Intranasal and Oculeve Extranasal 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 purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency. 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 and Oculeve Extranasal
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 2 sitesUnited States
Study dates: 31 Jan 2016to 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

Participants with aqueous tear deficiency
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 nasal cautery or significant trauma
Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
Diagnosis of epilepsy
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
A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Virginia Eye Consultants
Norfolk, Virginia, 23502
The Eye Care Group
Waterbury, Connecticut, 06708

Other trials in United States

About this study

Official title: A Randomized, Controlled, Double-Masked, Multicenter Trial Designed to Evaluate Acute Tear Production With the Oculeve Intranasal Lacrimal Stimulator Compared to Two Control Applications in Patients With Aqueous Deficient Dry Eye

The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.

Read the detailed description

This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in which participants with aqueous tear deficiency will receive three different device applications in a randomized sequence.

Conditions: Dry Eye Syndrome, Keratoconjunctivitis Sicca
Being tested: Oculeve Intranasal, Sham, Oculeve Extranasal
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 IntranasalDevice
Oculeve device, intranasal (test) application for approximately 3 minutes.
ShamDevice
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve ExtranasalDevice
Oculeve device, extranasal (control) application for approximately 3 minutes.

Study groups in NCT02680158
Study group	Role	What they receive
Sequence 1-Intranasal: Extranasal: Sham	Experimental	Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application. Receives: Device: Oculeve Intranasal; Device: Sham; Device: Oculeve Extranasal
Sequence 2-Intranasal: Sham: Extranasal	Experimental	Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application. Receives: Device: Oculeve Intranasal; Device: Sham; Device: Oculeve Extranasal
Sequence 3-Extranasal: Intranasal: Sham	Experimental	Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application. Receives: Device: Oculeve Intranasal; Device: Sham; Device: Oculeve Extranasal
Sequence 4-Extranasal: Sham: Intranasal	Experimental	Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application. Receives: Device: Oculeve Intranasal; Device: Sham; Device: Oculeve Extranasal
Sequence 5-Sham: Intranasal: Extranasal	Experimental	Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application. Receives: Device: Oculeve Intranasal; Device: Sham; Device: Oculeve Extranasal
Sequence 6-Sham: Extranasal: Intranasal	Experimental	Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application. Receives: Device: Oculeve Intranasal; Device: Sham; Device: Oculeve Extranasal

What is being measured

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

Acute Stimulated Tear Production
Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.
Measured: Day 0 post-application
Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)
An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.
Measured: Day 0

Timeline

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

31 Jan 201631 Mar 2016

First posted11 Feb 2016 (estimated)
Study start31 Jan 2016
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 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: Randomised
Intervention model: Crossover
Model description: Three way cross-over study with 6 sequences.
Masking: Single blind
Who is masked: Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02680158
Sponsor's protocol ID: OCUN-009
Status last verified: Apr 2019
First submitted: 21 Jan 2016
Last updated: 26 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

Sheppard JD, Torkildsen GL, Geffin JA, Dao J, Evans DG, Ousler GW, Wilson J, Baba SN, Senchyna M, Holland EJ. Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials. Ocul Surf. 2019 Jan;17(1):142-150. doi: 10.1016/j.jtos.2018.11.009. Epub 2018 Nov 22.
PubMed 30472141

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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Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled, Double-Masked, Multicenter Trial Designed to Evaluate Acute Tear Production With the Oculeve Intranasal Lacrimal Stimulator Compared to Two Control Applications in Patients With Aqueous Deficient Dry Eye
ClinicalTrials.gov ID: NCT02680158
Acronym / sponsor ID: OCUN-009
Conditions: Dry Eye Syndrome, Keratoconjunctivitis Sicca
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Oculeve, Inc.Industry (pharma, biotech, devices)
Study start: 31 Jan 2016 (actual)
Primary completion: 31 Mar 2016 (actual)
Study completion: 31 Mar 2016 (actual)
First posted: 11 Feb 2016 (estimated)
Results: Posted 26 Apr 2019

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 compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 6
Model description: Three way cross-over study with 6 sequences.

Arm	Type	Receives
Sequence 1-Intranasal: Extranasal: Sham	Experimental	Device: Oculeve Intranasal, Device: Sham, Device: Oculeve ExtranasalOculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Sequence 2-Intranasal: Sham: Extranasal	Experimental	Device: Oculeve Intranasal, Device: Sham, Device: Oculeve ExtranasalOculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Sequence 3-Extranasal: Intranasal: Sham	Experimental	Device: Oculeve Intranasal, Device: Sham, Device: Oculeve ExtranasalOculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Sequence 4-Extranasal: Sham: Intranasal	Experimental	Device: Oculeve Intranasal, Device: Sham, Device: Oculeve ExtranasalOculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Sequence 5-Sham: Intranasal: Extranasal	Experimental	Device: Oculeve Intranasal, Device: Sham, Device: Oculeve ExtranasalSham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Sequence 6-Sham: Extranasal: Intranasal	Experimental	Device: Oculeve Intranasal, Device: Sham, Device: Oculeve ExtranasalSham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.

Who may qualify

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

Key inclusion criteria (3 listed)

Participants with aqueous tear deficiency
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 (7 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 nasal cautery or significant trauma
Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
Diagnosis of epilepsy
Corneal transplant in either or both eyes

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 IntranasalOculeve device, intranasal (test) application for approximately 3 minutes.	Device	Sequence 1-Intranasal: Extranasal: Sham, Sequence 2-Intranasal: Sham: Extranasal, Sequence 3-Extranasal: Intranasal: Sham, Sequence 4-Extranasal: Sham: Intranasal, Sequence 5-Sham: Intranasal: Extranasal, Sequence 6-Sham: Extranasal: Intranasal
ShamSham device (control), intranasal application for approximately 3 minutes.	Device	Sequence 1-Intranasal: Extranasal: Sham, Sequence 2-Intranasal: Sham: Extranasal, Sequence 3-Extranasal: Intranasal: Sham, Sequence 4-Extranasal: Sham: Intranasal, Sequence 5-Sham: Intranasal: Extranasal, Sequence 6-Sham: Extranasal: Intranasal
Oculeve ExtranasalOculeve device, extranasal (control) application for approximately 3 minutes.	Device	Sequence 1-Intranasal: Extranasal: Sham, Sequence 2-Intranasal: Sham: Extranasal, Sequence 3-Extranasal: Intranasal: Sham, Sequence 4-Extranasal: Sham: Intranasal, Sequence 5-Sham: Intranasal: Extranasal, Sequence 6-Sham: Extranasal: Intranasal

Primary outcome

Acute Stimulated Tear Production
Time frame: Day 0 post-application
Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.
Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)
Time frame: Day 0
An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.

Results and safety

Results posted to the registry on 26 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1 - Intranasal : Extranasal : Sham	8	8
Sequence 2 - Intranasal : Sham : Extranasal	8	8
Sequence 3 - Extranasal: Intranasal: Sham	8	8
Sequence 4 - Extranasal : Sham : Intranasal	8	8
Sequence 5 - Sham : Intranasal : Extranasal	8	8
Sequence 6 - Sham : Extranasal : Intranasal	8	8

Primary outcome: Acute Stimulated Tear Production

Time frame: Day 0 post-application. Mean (Standard Deviation). Unit: mm

Measure	Oculeve Intranasal n = 48	Sham n = 48	Oculeve Extranasal n = 48
Value	25.3 (10.70)	9.2 (7.34)	9.5 (8.15)

Population analysed: The FAS population included all randomized participants who were exposed to study application.

Primary outcome: Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)

Time frame: Day 0. Number. Unit: percentage of participants

Measure	Oculeve Intranasal n = 48	Sham n = 48	Oculeve Extranasal n = 48
Device-related AEs (Ocular)	0	0	0
Device-related AEs (Non-ocular)	4.2	0	0

Population analysed: Safety population included all randomized participants who were exposed to study application.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Oculeve Intranasal	0 of 48 (0%)	4 of 48 (8.3%)	0 of 48
Sham	0 of 48 (0%)	0 of 48 (0%)	0 of 48
Oculeve Extranasal	0 of 48 (0%)	0 of 48 (0%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30472141Sheppard JD, Torkildsen GL, Geffin JA, Dao J, Evans DG, Ousler GW, Wilson J, Baba SN, Senchyna M, Holland EJ. Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials. Ocul Surf. 2019 Jan;17(1):142-150. doi: 10.1016/j.jtos.2018.11.009. Epub 2018 Nov 22.
Individual participant dataSharing planned: Undecided

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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 director

Allergan

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 and Oculeve Extranasal 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 7 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 26 Apr 2019. 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 26 Apr 2019). 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?

Acute Stimulated Tear Production (time frame: Day 0 post-application). The study lists 2 primary outcomes in all. 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 NCT02680158, 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 26 Apr 2019.