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Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oculeve Intranasal Lacrimal Neurostimulator
Sponsored by
Oculeve, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dry Eye Syndromes

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grutzmacher, Lewis & Sierra
  • Baylor College of Medicine, Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intranasal then Extranasal Application

Extranasal then Intranasal Application

Arm Description

Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.

Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.

Outcomes

Primary Outcome Measures

Fluorescein Tear Clearance With Application

Secondary Outcome Measures

Full Information

First Posted
March 2, 2015
Last Updated
September 22, 2021
Sponsor
Oculeve, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02385292
Brief Title
Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation
Official Title
Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 31, 2015 (Actual)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
March 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oculeve, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intranasal then Extranasal Application
Arm Type
Experimental
Arm Description
Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
Arm Title
Extranasal then Intranasal Application
Arm Type
Active Comparator
Arm Description
Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
Intervention Type
Device
Intervention Name(s)
Oculeve Intranasal Lacrimal Neurostimulator
Intervention Description
The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.
Primary Outcome Measure Information:
Title
Fluorescein Tear Clearance With Application
Time Frame
Day 1
Other Pre-specified Outcome Measures:
Title
Level of Tear Proteins Pre and Post Administration
Time Frame
Day 1
Title
Level of Inflammatory Mediators Pre and Post Administration
Time Frame
Day 1
Title
Goblet Cell Count Following Application
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Lewis, MD
Organizational Affiliation
Grutzmacher, Lewis & Sierra
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grutzmacher, Lewis & Sierra
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Baylor College of Medicine, Department of Ophthalmology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28302532
Citation
Gumus K, Schuetzle KL, Pflugfelder SC. Randomized Controlled Crossover Trial Comparing the Impact of Sham or Intranasal Tear Neurostimulation on Conjunctival Goblet Cell Degranulation. Am J Ophthalmol. 2017 May;177:159-168. doi: 10.1016/j.ajo.2017.03.002. Epub 2017 Mar 14.
Results Reference
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Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

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