Artificial Tears, Tear Lipids and Tear Film Dynamics

Study Overview
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Brief Summary
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Dry eye disease (DED) is pervasive with some reports estimating over 16 million adults diagnosed in the United States. Currently, artificial tears remain an integral part of managing dry eyes and are mainly used for symptomatic relief. Recent studies have shown there may be therapeutic benefits with regular use of lipid-based artificial tears to improve the structure of the tear film, which may improve tear film stability and provide relief of symptoms. In this study the investigators propose to compare effects on the tear lipid film and its dynamics between 3 lipid based artificial tears and a widely available non-lipid based artificial tear.

Detailed Description
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This is a prospective, double-masked, randomized, controlled, parallel-group trial designed to compare the impact of Systane Complete PF lipid-based artificial tears (the Treatment solution under study) on tear lipid layer thickness compared with a non-lipid Control solution, Refresh Relieva PF. Secondarily, the study will compare changes in tear lipid layer thickness, lipid layer uniformity, tear film thinning dynamics, and symptoms between the Treatment solution, the non-lipid Control solution, and 2 other available lipid-based solutions (Active Comparators: Refresh Optive Mega-3 PF and CVS Health Lubricant Eye Drop (PG 0.6%)). The study will include 4 clinic visits, and require 1 week of single-masked run-in with Systane Ultra PF (an over-the-counter non-lipid-based solution) followed by 3 months of study treatment dosing. All subjects will complete a screening interview, then an in-clinic baseline ocular health examination and study eligibility determination followed by dispensing of the Control solution to all subjects for 1 week of run-in. After that week, subjects will be randomized to 1 of the 4 artificial tear solutions and have an in-clinic ocular examination and dispense of the assigned solution to use for 3 months. An in-clinic follow-up examination is completed after 1 month of study solution use, followed by a phone interview at 2 months, and a final in-clinic examination at 3 months post-dispensing.

Official Title
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Effects Of Artificial Tears on Tear Lipid Films and Tear Film Dynamics In Vivo

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Systane Complete PF
* Drug: Refresh Relieva PF
* Drug: Refresh Optive Mega-3 PF
* Drug: CVS Health Lubricant Eye Drop (PG 0.6%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Best Corrected Visual Acuity of 20/30 or better; Experiencing Dry Eye symptoms (baseline OSDI score >= 13); Exclusion Criteria: Currently experiencing active ocular inflammation or infection; Currently using topical eye medication (not including over-the-counter eyedrops); Having systemic health conditions or using prescription medications (including but not limited to isotretinoin derivatives) that could alter tear film physiology; Having a history of severe ocular trauma, ocular surgery, or diabetes; Being pregnant or breast feeding; Being a current contact lens wearer; Currently having a condition or being in a situation which, in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may otherwise significantly interfere with their participation in the study;

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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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Complete PF (Treatment)<br>Masked subjects assigned to Arm 1 will use Systane Complete PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period. | Drug: Systane Complete PF<br>* 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product<br>|
| Placebo Comparator: Refresh Relieva PF (Control)<br>Masked subjects assigned to Arm 2 will use Refresh Relieva PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period. | Drug: Refresh Relieva PF<br>* 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product<br>|
| Active Comparator: Refresh Optive Mega-3 PF (Active Comparator 1)<br>Masked subjects assigned to Arm 3 will use Refresh Optive Mega-3 PF artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period. | Drug: Refresh Optive Mega-3 PF<br>* 3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product<br>|
| Active Comparator: CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)<br>Masked subjects assigned to Arm 4 will use CVS Health Lubricant Eye Drop (PG 0.6%) artificial tear drops 4 times per day (QID) to treat dry eye symptoms over a 3 month period. | Drug: CVS Health Lubricant Eye Drop (PG 0.6%)<br>* 3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Lipid Layer Thickness | Change in Tear Lipid Layer Thickness (3mo follow-up - post-run-in baseline) | Lipid Layer Thickness measured once at post-run-in baseline and once at 3mo follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Lipid Layer Uniformity | Change in Tear Lipid Layer Thickness Coefficient of Variation (3mo follow-up - post-run-in baseline) | Lipid Layer Uniformity measured once at post-run-in baseline and once at 3mo follow-up visit | 
| Tear Film Thinning Rate | Change in Tear Film Thinning rate (3mo follow-up - post-run-in baseline) | Tear Film Thinning Rate measured once at post-run-in baseline and once at 3mo follow-up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye, Tear Film Lipid Layer Dynamics, Tear Film Stability