Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users
NCT ID: NCT04763018
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
35 participants
INTERVENTIONAL
2021-02-17
2021-06-01
Brief Summary
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Detailed Description
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The study will be conducted at up to 5 sites in the United States. It will enroll 30 subjects for 30 days.
This is a double-masked study with 10 subjects receiving sham and 20 subjects receiving treatment. The subjects and the examining investigators are masked to treatment until the crossover.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Treatment
This arm will receive a function iTEAR
iTEAR100
Neurostimulation external nasal nerve to stimulate tear production
Sham
This arm will receive sham treatment device
iTEAR100
Neurostimulation external nasal nerve to stimulate tear production
Interventions
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iTEAR100
Neurostimulation external nasal nerve to stimulate tear production
Eligibility Criteria
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Inclusion Criteria
* OSDI \> 13
* One of: SChirmer \< 10, One quadrant staining \> 2, or Meibomian Gland expression \<12
Exclusion Criteria
18 Years
69 Years
ALL
No
Sponsors
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Olympic Ophthalmics, Inc.
INDUSTRY
Responsible Party
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Locations
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Fishman Vision
Palo Alto, California, United States
Countries
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Central Contacts
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Other Identifiers
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CLP-OO8
Identifier Type: -
Identifier Source: org_study_id
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