Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye
NCT ID: NCT02313454
Last Updated: 2020-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2014-11-17
2015-04-08
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
TREATMENT
SINGLE
Study Groups
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Intranasal Application
Intranasal Tear Neurostimulator device, intranasal application for approximately 3 minutes on Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
Intranasal Tear Neurostimulator
Neurostimulation applied intranasally and extranasally.
Extranasal Application
Intranasal Tear Neurostimulator device, extranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure.
Intranasal Tear Neurostimulator
Neurostimulation applied intranasally and extranasally.
Interventions
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Intranasal Tear Neurostimulator
Neurostimulation applied intranasally and extranasally.
Eligibility Criteria
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Inclusion Criteria
* Capable of providing written informed consent
Exclusion Criteria
* Uncontrolled systemic disease
* Blood coagulation disorder
* Females who are pregnant, nursing or planning a pregnancy
22 Years
ALL
No
Sponsors
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ORA, Inc.
INDUSTRY
Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Michelle Senchyna
Role: STUDY_CHAIR
Allergan
Locations
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Andover Eye Associates
Andover, Massachusetts, United States
Countries
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Other Identifiers
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OCUN-007
Identifier Type: -
Identifier Source: org_study_id
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