Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control

Study Overview
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Brief Summary
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This study will evaluate the increase in comfort and comfortable contact lens (CL) wear time associated with application of TrueTear (active intranasal neurostimulation) compared with application of TrueTear sham control (intranasal application which is not electrically active) in symptomatic CL wearers.

Official Title
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Randomized, Double-arm, Controlled Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control (CORIANDER)

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: TrueTear
* Device: TrueTear Sham Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A person is eligible for inclusion if he/she 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: Refractive error surgery 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TrueTear<br>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. | Device: TrueTear<br>* 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.<br>|
| Sham Comparator: TrueTear Sham Control<br>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. | Device: TrueTear Sham Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye | The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst). The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye. | Day 28 | 
| Comfort Rating Score in the Study Eye | The participant assessed contact lens comfort in the study eye using a 100 point scale where a score of 0=Extremely uncomfortable and a score of 100=Extremely comfortable. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye. | CL Insertion, After 2 hours and the End of Day on Day 24 | 
| Comfortable Wear Time (CWT) in the Study Eye | CWT was calculated by taking the difference between the time participants reported started to find their CLs getting uncomfortable and the reported insertion time for that day. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye. | Day 24 | 
| Total Wear Time (Total WT) in the Study Eye | Total WT was calculated by taking the difference between the time participants reported removing their CLs and the reported insertion time for that day. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye. | Day 24 |