NCT02910713

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

Multicenter, Randomized, Controlled, Single-Masked, Cross-Over Clinical Trial to Evaluate Dry Eye Symptoms With Application of the Oculeve Intranasal Tear Neurostimulator During Exposure to a Controlled Adverse Environment (CAE®)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	Intranasal Tear Neurostimulator	The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Timeline

• Start date: 2016-09-30
• Primary completion: 2016-10-31
• Completion: 2016-10-31
• First posted: 2016-09-22
• Last updated: 2020-01-31
• Results posted: 2020-01-31

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study