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

Allergan

Status: Completed

Conditions: Dry Eye Syndromes

Treatments: Device: Intranasal Tear Neurostimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT02910713

OCUN-011

Details and patient eligibility

About

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.

Full description

Participants will be randomized to a single application sequence, either sequence "A" (intranasal application followed by control application) or sequence "B" (control application followed by intranasal application) using the device. Upon entering the CAE, participants will complete dry eye questionnaires every five minutes and will administer the device either intranasally or extranasally in randomized sequence when a certain level of ocular discomfort has been reached.

Enrollment: 185 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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185 participants in 2 patient groups

Intranasal Application

Experimental group

Description:

Intranasal Tear Neurostimulator applied intranasally device (active), intranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.

Treatment:

Device: Intranasal Tear Neurostimulator

Extranasal Application

Sham Comparator group

Description:

Intranasal Tear Neurostimulator device applied extranasally (control) for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during the CAE exposure.

Treatment:

Device: Intranasal Tear Neurostimulator