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Completed

NCT Number: NCT02385292

Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

The objectives of this study are:

* To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications * To compare the goblet cell count following application between the intranasal and extranasal applications * To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grutzmacher, Lewis & Sierra, Sacramento, California, United States

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About this study

In this study, subjects will participate for three study days during up to a 44 day period, consisting of a screening examination to determine eligibility on one day and study applications on two different days. There are two applications, intranasal and extranasal. Subjects will receive both applications, in random sequence, one at each of the two application days (Visit 2 and Visit 3). The two applications consist of:

  • Active intranasal device application
  • Active extranasal device application

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bilateral dry eyes
  • Capable of providing written informed consent

Exclusion criteria

  • Chronic or recurring epistaxis (nosebleeds)
  • Blood coagulation disorder
  • Uncontrolled or poorly controlled diabetes
  • Heart or pulmonary disease
  • Females who are pregnant, planning a pregnancy or nursing

Treatment and study plan

Oculeve Intranasal Lacrimal Neurostimulator

Device

The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.

Primary outcomes

  1. Fluorescein Tear Clearance With Application

    Time frame: Day 1

Other outcomes

  1. Level of Tear Proteins Pre and Post Administration

    Time frame: Day 1

  2. Level of Inflammatory Mediators Pre and Post Administration

    Time frame: Day 1

  3. Goblet Cell Count Following Application

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Oculeve, Inc.

Industry

Registry information

Official study title

Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2015
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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