Tear Production by Nasal Neurostimulation Compared to Active Control

Sponsor
Oculeve, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02970799
Collaborator
(none)
27
2
2

Study Details

Study Description

Brief Summary

This crossover design study evaluates the effectiveness of the Oculeve Intranasal Neurostimulator comparing the effect of intranasal (active) versus extranasal (control) stimulation on tear production as measured by the Jones Schirmer test in participants with dry eye disease.

Condition or Disease Intervention/Treatment Phase
  • Device: Intranasal Neurostimulator
N/A

Detailed Description

In this randomized, controlled study, participants will receive two applications of approximately a three-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence at Visit 2 (Day 1). At Visits 3 (Day 15) and 4 (Day 29), participants will undergo two applications of approximately an eight-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence. The Schirmer test is a clinically relevant and accepted measure to assess tear production over a specified time interval, generally five minutes. Tear meniscus height (TMH) and, to a lesser extent, tear meniscus area (TMA) have been reported as measures of tear quantity and/or production and have been used to diagnose dry eye disease (DED). One reliable means of measuring TMH and TMA is via use of optical coherence tomography (OCT), an established medical imaging technique that uses light to capture micrometer-resolution images from within optical scattering media such as biological tissue. Due to the non-invasive nature of the technique, this study was designed to explore the utility of TMH and TMA captured by OCT as a means of evaluating stimulated tear production following use of the study device.

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Randomized, Controlled, Crossover Study Comparing Tear Production by Nasal Neurostimulation Versus Active Control
Actual Study Start Date :
Aug 31, 2016
Actual Primary Completion Date :
Oct 31, 2016
Actual Study Completion Date :
Oct 31, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intranasal then Extranasal Application

Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.

Device: Intranasal Neurostimulator
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Experimental: Extranasal then Intranasal Application

Intranasal Neurostimulator applied extranasally (control) followed by intranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence at Days 15 and 29.

Device: Intranasal Neurostimulator
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Outcome Measures

Primary Outcome Measures

  1. Acute Tear Production by Jones Schirmer Test [Day 1]

Other Outcome Measures

  1. Tear Meniscus Height [Pre and Post Application on Days 15 and 29]

  2. Tear Meniscus Area [Pre and Post Application Days 15 and 29]

  3. Number of Secreting Meibomian Glands [Day 1]

  4. Tear Film Lipid Layer Thickness by Tearscope [Pre and Post Application on Days 15 and 29]

  5. Lower Lid Margin Temperature [Pre and Post Application on Days 15 and 29]

  6. Tear Film Temperature [Pre and Post Application on Days 15 and 29]

  7. Number of Participants With Adverse Events [Up to 41 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Mild to severe dry eye disease

  • Have not worn contact lenses for at least seven days prior to the Screening Visit and willing to forego the use of contact lenses for the duration of the study

  • Literate, able to speak English or Spanish, and able to complete questionnaires independently

Exclusion Criteria:
  • Previously used the Intranasal Neurostimulator at any time

  • Used commercial lid hygiene product within 14 days of the Screening Visit or plan to use at any time during the study

  • Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to the risk of clinically significant increased bleeding

  • Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas

  • Severe nasal airway obstruction (e.g. severe septal deviation or inferior turbinate hypertrophy) or vascularized polyp as confirmed by nasal endoscopic examination at the Screening Visit

  • Have an implanted metallic or other electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator

  • Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Oculeve, Inc.

Investigators

  • Principal Investigator: Gail Torkildsen, MD, Andover Eye Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oculeve, Inc.
ClinicalTrials.gov Identifier:
NCT02970799
Other Study ID Numbers:
  • OCUN-016B
First Posted:
Nov 22, 2016
Last Update Posted:
Oct 19, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Oculeve, Inc.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Arm/Group Title Intranasal Then Extranasal Application Extranasal Then Intranasal Application
Arm/Group Description Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29. Intranasal Neurostimulator applied extranasally (control) on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.
Period Title: Overall Study
STARTED 0 0
COMPLETED 0 0
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Intranasal Then Extranasal Application Extranasal Then Intranasal Application Total
Arm/Group Description Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29. Intranasal Neurostimulator applied extranasally (control) on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29. Total of all reporting groups
Overall Participants 0 0 0
Age (years) []
Sex: Female, Male (participants) []
Female
Male

Outcome Measures

1. Primary Outcome
Title Acute Tear Production by Jones Schirmer Test
Description
Time Frame Day 1

Outcome Measure Data

Analysis Population Description
During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Arm/Group Title Intranasal Application Extranasal Application
Arm/Group Description Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.
Measure Participants 0 0
2. Other Pre-specified Outcome
Title Tear Meniscus Height
Description
Time Frame Pre and Post Application on Days 15 and 29

Outcome Measure Data

Analysis Population Description
During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Arm/Group Title Intranasal Application Extranasal Application
Arm/Group Description Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.
Measure Participants 0 0
3. Other Pre-specified Outcome
Title Tear Meniscus Area
Description
Time Frame Pre and Post Application Days 15 and 29

Outcome Measure Data

Analysis Population Description
During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Arm/Group Title Intranasal Application Extranasal Application
Arm/Group Description Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.
Measure Participants 0 0
4. Other Pre-specified Outcome
Title Number of Secreting Meibomian Glands
Description
Time Frame Day 1

Outcome Measure Data

Analysis Population Description
During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Arm/Group Title Intranasal Application Extranasal Application
Arm/Group Description Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.
Measure Participants 0 0
5. Other Pre-specified Outcome
Title Tear Film Lipid Layer Thickness by Tearscope
Description
Time Frame Pre and Post Application on Days 15 and 29

Outcome Measure Data

Analysis Population Description
During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Arm/Group Title Intranasal Application Extranasal Application
Arm/Group Description Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.
Measure Participants 0 0
6. Other Pre-specified Outcome
Title Lower Lid Margin Temperature
Description
Time Frame Pre and Post Application on Days 15 and 29

Outcome Measure Data

Analysis Population Description
During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Arm/Group Title Intranasal Application Extranasal Application
Arm/Group Description Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.
Measure Participants 0 0
7. Other Pre-specified Outcome
Title Tear Film Temperature
Description
Time Frame Pre and Post Application on Days 15 and 29

Outcome Measure Data

Analysis Population Description
During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Arm/Group Title Intranasal Application Extranasal Application
Arm/Group Description Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.
Measure Participants 0 0
8. Other Pre-specified Outcome
Title Number of Participants With Adverse Events
Description
Time Frame Up to 41 days

Outcome Measure Data

Analysis Population Description
During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Arm/Group Title Intranasal Application Extranasal Application
Arm/Group Description Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.
Measure Participants 0 0

Adverse Events

Time Frame
Adverse Event Reporting Description During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Arm/Group Title Intranasal Application Extranasal Application
Arm/Group Description Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29.
All Cause Mortality
Intranasal Application Extranasal Application
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Serious Adverse Events
Intranasal Application Extranasal Application
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Intranasal Application Extranasal Application
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)

Limitations/Caveats

During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Authorship and manuscript composition will reflect cooperation among all parties involved in the study. Authorship will be established before writing the manuscript. The study sponsor and Ora will have the final decision regarding the manuscript and publication.

Results Point of Contact

Name/Title Therapeutic Area, Head
Organization Allergan
Phone 714-246-4500
Email clinicaltrials@allergan.com
Responsible Party:
Oculeve, Inc.
ClinicalTrials.gov Identifier:
NCT02970799
Other Study ID Numbers:
  • OCUN-016B
First Posted:
Nov 22, 2016
Last Update Posted:
Oct 19, 2021
Last Verified:
Sep 1, 2021