Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

Study Overview
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Brief Summary
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This study will evaluate the change in tear meniscus height (TMH) produced by intranasal stimulation with TrueTear™ compared with the same device applied extranasally (control).

Official Title
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Randomized, Controlled, Single-Center, Cross-Over Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: TrueTear™ Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Baseline Ocular Surface Disease Index© (OSDI©) score of at least 23 with no more than three responses of not applicable In at least one eye, a baseline Schirmer test of ≤ 10 mm/5 minutes AND a cotton swab nasal stimulation Schirmer test of at least 7 mm higher in the same eye 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 Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of 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: 18 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TrueTear™ Intranasal then Extranasal Application<br>TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 14. | Device: TrueTear™ Application<br>* Intranasal and extranasal application of TrueTear™ device for approximately 3 minutes at Day 0 and Day 14.<br>|
| Experimental: TrueTear™ Extranasal then Intranasal Application<br>TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 14. | Device: TrueTear™ Application<br>* Intranasal and extranasal application of TrueTear™ device for approximately 3 minutes at Day 0 and Day 14.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink | Tear meniscus height is defined as the mean height of the lower tear prism to the edge of the eye lid measured by the investigator using the Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to time (T) T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 minutes (mins) after application was reported. A negative change from Baseline (Pre-application) indicates improvement. | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application | 
| Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink | Lipid layer thickness is defined as the average thickness of the lipid layer calculated from the thickness of the various pattern weighted by the relative coverage of each pattern measured by the investigator using the Tearscope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported. A negative change from Baseline (Pre-application) indicates improvement . | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application | 
| Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT) | Non-invasive break-up time is the time in seconds between eye opening and the appearance of the first visible break in the lipid layer of the pre-corneal tear film measured by the investigator using the Tearscope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported. A negative change from Baseline (Pre-application) indicates improvement. | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application | 
| Change From Pre-application in Protective Index (PI) | The Protected Index (PI) corresponds to the percentage of the corneal surface that is not exposed to the atmosphere (i.e. fully covered by the tear film) over the full interblink period measured by the investigator using a Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported. | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application | 
| Change From Pre-application in Exposed Area (EA) | Exposed Area is defined as the percentage of the observed area not covered by the tear film at the time of the blink hence exposed to the atmosphere measured by the investigator using a Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported. | Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application |