Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control
NCT ID: NCT03325673
Last Updated: 2019-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2017-11-22
2018-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TrueTear
TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on contact lens (CL) wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.
TrueTear
TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.
TrueTear Sham Control
TrueTear sham device, which is not electrically active and has limited tip insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
TrueTear Sham Control
TrueTear sham device, which is not electrically active and has limited tip insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
Interventions
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TrueTear
TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.
TrueTear Sham Control
TrueTear sham device, which is not electrically active and has limited tip insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
Eligibility Criteria
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Inclusion Criteria
* In at least one eye, has a cotton swab nasal stimulation Schirmer test score at least 4 mm greater than 3 minute Schirmer with anesthesia basal score in the same eye at the Screening Visit
* Is an adapted soft contact lens wearer and currently wears lenses an average of at least 2 days per week, with an average minimum wearing time of 3 hours each day over the past month and is able and willing to wear lenses for at least 6 hours on four study day visits
* Has at least 20/40 visual acuity in both eyes with CL correction
* Is symptomatic according to Young's categorization
Exclusion Criteria
* Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding
* History of nasal or sinus surgery
* Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit
* Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
22 Years
ALL
No
Sponsors
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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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Centre for Contact Lens Research School of Optometry & Vision Science, University of Waterloo
Waterloo, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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OCUN-024
Identifier Type: -
Identifier Source: org_study_id