N/A
N=27
Tear Production by Nasal Neurostimulation Compared to Active Control
Dry Eye · Dry Eye Syndromes · Keratoconjunctivitis Sicca
Bottom Line
View on ClinicalTrials.gov: NCT02970799 ↗Enrolled (actual)
27
Serious AEs
—
Results posted
Oct 2021
Primary outcome: Primary: Acute Tear Production by Jones Schirmer Test
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intranasal Neurostimulator (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Oculeve, Inc.
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Tear Production by Jones Schirmer Test |
— | — |
Summary
This crossover design study evaluates the effectiveness of the Oculeve Intranasal Neurostimulator comparing the effect of intranasal (active) versus extranasal (control) stimulation on tear production as measured by the Jones Schirmer test in participants with dry eye disease.
Eligibility Criteria
Inclusion Criteria
- Mild to severe dry eye disease
- Have not worn contact lenses for at least seven days prior to the Screening Visit and willing to forego the use of contact lenses for the duration of the study
- Literate, able to speak English or Spanish, and able to complete questionnaires independently
Exclusion Criteria
- Previously used the Intranasal Neurostimulator at any time
- Used commercial lid hygiene product within 14 days of the Screening Visit or plan to use at any time during the study
- Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to the risk of clinically significant increased bleeding
- Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
- Severe nasal airway obstruction (e.g. severe septal deviation or inferior turbinate hypertrophy) or vascularized polyp as confirmed by nasal endoscopic examination at the Screening Visit
- Have an implanted metallic or other electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
- Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
Data sourced from ClinicalTrials.gov (NCT02970799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.