A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome
NCT ID: NCT02680158
Last Updated: 2019-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2016-01-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Sequence 1-Intranasal: Extranasal: Sham
Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
Sham
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.
Sequence 2-Intranasal: Sham: Extranasal
Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
Sham
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.
Sequence 3-Extranasal: Intranasal: Sham
Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
Sham
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.
Sequence 4-Extranasal: Sham: Intranasal
Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
Sham
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.
Sequence 5-Sham: Intranasal: Extranasal
Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
Sham
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.
Sequence 6-Sham: Extranasal: Intranasal
Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
Sham
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.
Interventions
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Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
Sham
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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
* Nasal or sinus surgery including nasal cautery or significant trauma
* Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
* Diagnosis of epilepsy
* 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
* A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit
22 Years
ALL
No
Sponsors
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Oculeve, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michelle Senchyna
Role: STUDY_DIRECTOR
Allergan
Locations
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The Eye Care Group
Waterbury, Connecticut, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Countries
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References
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Sheppard JD, Torkildsen GL, Geffin JA, Dao J, Evans DG, Ousler GW, Wilson J, Baba SN, Senchyna M, Holland EJ. Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials. Ocul Surf. 2019 Jan;17(1):142-150. doi: 10.1016/j.jtos.2018.11.009. Epub 2018 Nov 22.
Other Identifiers
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OCUN-009
Identifier Type: -
Identifier Source: org_study_id
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