Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation

Completed · Not applicable

Conditions studied: Dry Eye Syndromes

In brief

This study evaluates the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally (active) compared with the same device applied extranasally (control) relating to symptoms of dry eye exacerbated by the Controlled Adverse Environment model.

Key facts

Study ID

NCT02910713

Run by

Allergan

People needed

185

Starts

2016-09-30

Expected to finish

2016-10-31

Last updated by the study team

2020-01-31

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderate to severe dry eye disease
• Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
• Literate, able to speak English, and able to complete questionnaires independently

You may not qualify if…

• Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding
• Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
• Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
• Corneal transplant in either or both eyes
• A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit
• Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit

Where it is running

• Eye Care Institute — Louisville, Kentucky, United States
• Total Eye Care, PA — Memphis, Tennessee, United States
• Nashville Vision Associates — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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