Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator (NCT02526290) | Clinical Trial Compass
CompletedNot Applicable
Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator
United States97 participantsStarted 2015-08-31
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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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
What they're measuring
1
Stimulated Acute Tear Production
Timeframe: The stimulated and prestimulation (basal) measures were both performed at Day 180.