N/A
N=97
Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator
Dry Eye Syndromes · Keratoconjunctivitis Sicca
Bottom Line
View on ClinicalTrials.gov: NCT02526290 ↗Enrolled (actual)
97
Serious AEs
8.3%
Results posted
Oct 2017
Primary outcome: Primary: Stimulated Acute Tear Production — 17.28; 7.92 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intranasal Lacrimal Neurostimulator (Oculeve) (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Oculeve, Inc.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stimulated Acute Tear Production |
17.28; 7.92 | — |
| SECONDARY Corrected Distance Visual Acuity |
-0.028; -0.033 | — |
| SECONDARY Slit Lamp Biomicroscopy |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02526290). 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.