1-Day Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:22 - Any
Updated:4/21/2016
Start Date:January 2016
End Date:March 2016

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A Randomized, Controlled, Double-Masked, Multicenter Trial Designed to Evaluate Acute Tear Production With the Oculeve Intranasal Lacrimal Stimulator Compared to Two Control Applications in Patients With Aqueous Deficient Dry Eye

The purpose of this study is to compare acute tear production produced by the Oculeve
Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous
tear deficiency.

This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in
which subjects with aqueous tear deficiency will receive three different device applications
in a randomized sequence.

Inclusion Criteria:

- Subjects with aqueous tear deficiency

- 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 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

- A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit
We found this trial at
2
sites
Waterbury, Connecticut 06708
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Waterbury, CT
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Norfolk, Virginia 23502
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Norfolk, VA
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