Dry Eye SyndromesNCT02526290
Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator
A study testing Intranasal Lacrimal Neurostimulator (Oculeve) in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Oculeve, Inc. at 3 sites in United States.
Trial summary
In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be evaluated. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- What is being tested?
- Intranasal Lacrimal Neurostimulator (Oculeve)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Aug 2015to 30 Apr 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 moderate to severe 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
- 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
- Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Total Eye Care
Memphis, Tennessee, 38119
Cornea & Cataract Consultants of Arizona
Phoenix, Arizona, 85032
About this study
Official title: Single-Arm, Multicenter, Open-Label Study to Evaluate the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Participants With Aqueous Tear Deficient Dry Eye
In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be evaluated.
Read the detailed description
This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the Oculeve Intranasal Lacrimal Neurostimulator to stimulate tear production for 180 days. Participants will have a Screening Visit within 60 days prior to the initial device application. Device application will be initiated at Day 0, at which time participants will receive training on the proper use of the device. Participants will receive follow-up visits at Days 7, 30, 90 and 180.
- Conditions
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- Being tested
- Intranasal Lacrimal Neurostimulator (Oculeve)
- 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.
Intranasal Lacrimal Neurostimulator (Oculeve)Device
Neurostimulation device
| Study group | Role | What they receive |
|---|---|---|
| Active - Device | Experimental | The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. Receives: Device: Intranasal Lacrimal Neurostimulator (Oculeve) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulated Acute Tear Production
Stimulated acute tear production in the study eye at Day 180 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.
Measured: The stimulated and prestimulation (basal) measures were both performed at Day 180.
Secondary outcomes (2)
Corrected Distance Visual Acuity
Change from baseline (Day 0) in corrected distance visual acuity at Day 180. Corrected visual acuity was obtained using the subject's own glasses (for subjects that wear glasses) and measured in logMAR (log of the Minimum Angle of Resolution) units using an appropriate eye chart. A logMAR score of 0.0 is equivalent to a visual acuity of 20/20 and larger logMAR values indicate a poorer visual acuity (eg. A value of 0.3 corresponds to a visual acuity of 20/40).
Measured: Baseline and 6 months
Slit Lamp Biomicroscopy
Number of subjects with clinically significant (CS) findings noted from the slit lamp biomicroscopy examinations. A slit lamp biomicroscopy examination of the eyelids, cornea, conjunctiva, anterior chamber, and lens was performed at each visit for each eye. The results were graded as normal, abnormal not clinically significant (NCS), or abnormal CS. In addition, the cornea was scored specifically for corneal edema using a 4-point scale (0=None, +1=Mild, +2=Moderate and +3=Severe). An increase in corneal edema grade of two or more was considered clinically significant and evaluated as a potential AE by the investigator.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start31 Aug 2015
- Primary completion30 Apr 2016
- Study completion30 Apr 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oculeve, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Holland, MD, Study director, Cincinnati Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526290
- Sponsor's protocol ID
- OCUN-010
- Status last verified
- Sep 2017
- First submitted
- 14 Aug 2015
- Last updated
- 31 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Arm, Multicenter, Open-Label Study to Evaluate the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Participants With Aqueous Tear Deficient Dry Eye
- ClinicalTrials.gov ID
- NCT02526290
- Acronym / sponsor ID
- OCUN-010
- Conditions
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Oculeve, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Posted 31 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be evaluated.
Detailed description
This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the Oculeve Intranasal Lacrimal Neurostimulator to stimulate tear production for 180 days. Participants will have a Screening Visit within 60 days prior to the initial device application. Device application will be initiated at Day 0, at which time participants will receive training on the proper use of the device. Participants will receive follow-up visits at Days 7, 30, 90 and 180.
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: Intranasal Lacrimal Neurostimulator (Oculeve)The Oculeve Intranasal Lacrimal Neurostimulator will be administered two to ten times per day for up to three minutes per administration. |
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 moderate to severe 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 (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 history of application of 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 |
|---|---|---|
| Intranasal Lacrimal Neurostimulator (Oculeve)Neurostimulation device | Device | Active - Device |
Primary outcome
Stimulated Acute Tear Production
Time frame: The stimulated and prestimulation (basal) measures were both performed at Day 180.
Stimulated acute tear production in the study eye at Day 180 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.
2 secondary outcomes
Corrected Distance Visual Acuity
Time frame: Baseline and 6 months
Slit Lamp Biomicroscopy
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- 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.
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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.
Edward Holland, MD study director
Cincinnati Eye Institute
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 Lacrimal Neurostimulator (Oculeve) in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Oculeve, Inc. 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 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 31 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 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. 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 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?
Stimulated Acute Tear Production (time frame: The stimulated and prestimulation (basal) measures were both performed at Day 180.). 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 NCT02526290, 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 31 Oct 2017.