Back to resultsAcute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
Primary Purpose
Dry Eye Syndrome, Keratoconjunctivitis Sicca
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oculeve Intranasal Neurostimulator
Sponsored by
About this trial
This is an interventional supportive care trial for Dry Eye Syndrome
Eligibility Criteria
Inclusion Criteria:
- Subjects with dry eye disease
- Literate, able to speak English or Spanish, and able to complete questionnaires independently
- Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
Exclusion Criteria:
- Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
- Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma
- Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
- Corneal transplant in either or both eyes
- Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
- Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit
Sites / Locations
- Sall Research Medical Center
- Aesthetic Eyecare Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active - Device
Arm Description
The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment.
Outcomes
Primary Outcome Measures
Tear Meniscus Height Captured by Optical Coherence Tomography
Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02798289
Brief Title
Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
Official Title
A Single Arm, Multicenter, Open-Label Study Designed to Evaluate Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oculeve, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.
Detailed Description
This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome, Keratoconjunctivitis Sicca
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active - Device
Arm Type
Experimental
Arm Description
The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment.
Intervention Type
Device
Intervention Name(s)
Oculeve Intranasal Neurostimulator
Intervention Description
Neurostimulation device
Primary Outcome Measure Information:
Title
Tear Meniscus Height Captured by Optical Coherence Tomography
Description
Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with dry eye disease
Literate, able to speak English or Spanish, and able to complete questionnaires independently
Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
Exclusion Criteria:
Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma
Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
Corneal transplant in either or both eyes
Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Friedman, MD
Organizational Affiliation
Mid-Peninsula Ophthalmology Medical Group
Official's Role
Study Director
Facility Information:
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Aesthetic Eyecare Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
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