Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

September 22, 2021 updated by: Oculeve, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95815
        • Grutzmacher, Lewis & Sierra
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intranasal then Extranasal Application
Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
Device: Oculeve Intranasal Lacrimal Neurostimulator
The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.
Active Comparator: Extranasal then Intranasal Application
Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
Device: Oculeve Intranasal Lacrimal Neurostimulator
The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fluorescein Tear Clearance With Application
Time Frame: Day 1
Day 1

Other Outcome Measures

Outcome Measure
Time Frame
Level of Tear Proteins Pre and Post Administration
Time Frame: Day 1
Day 1
Level of Inflammatory Mediators Pre and Post Administration
Time Frame: Day 1
Day 1
Goblet Cell Count Following Application
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oculeve, Inc.

Investigators

  • Principal Investigator: Richard Lewis, MD, Grutzmacher, Lewis & Sierra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2015

Primary Completion (Actual)

March 31, 2016

Study Completion (Actual)

March 31, 2016

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCUN-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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