Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator (NCT02798289) | Clinical Trial Compass
CompletedNot Applicable
Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
United States55 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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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
What they're measuring
1
Tear Meniscus Height Captured by Optical Coherence Tomography