N/A N=55 Supportive Care

Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

Dry Eye Syndrome · Keratoconjunctivitis Sicca

Bottom Line

View on ClinicalTrials.gov: NCT02798289 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcome: Primary: Tear Meniscus Height Captured by Optical Coherence Tomography — 238.4; 634.9 µm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Oculeve Intranasal Neurostimulator (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Oculeve, Inc.
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Tear Meniscus Height Captured by Optical Coherence Tomography	238.4; 634.9	—

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.

Eligibility Criteria

Inclusion Criteria

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

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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02798289). 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.