Artificial Tears, Tear Lipids and Tear Film Dynamics

Phase 4

Completed

• Conditions: Dry Eye
• Interventions: Drug: Refresh Optive Mega-3 PF; Drug: CVS Health Lubricant Eye Drop (PG 0.6%); Drug: Systane Complete PF; Drug: Refresh Relieva PF

• Registration Number: NCT05705518
• Lead Sponsor: University of California, Berkeley

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-20
• Study Start: 2023-01-30
• Study First Posted: 2023-01-30
• Primary Completion: 2023-09-30
• Study Completion: 2024-01-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Best Corrected Visual Acuity of 20/30 or better;
• Experiencing Dry Eye symptoms (baseline OSDI score >= 13);

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Refresh Optive Mega-3 PF (Active Comparator 1)	Refresh Optive Mega-3 PF	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.
CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)	CVS Health Lubricant Eye Drop (PG 0.6%)	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.
Systane Complete PF (Treatment)	Systane Complete PF	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.
Refresh Relieva PF (Control)	Refresh Relieva PF	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.

Primary Outcome Measures

Name	Time	Method
Tear Lipid Layer Thickness	Lipid Layer Thickness measured once at post-run-in baseline and once at 3mo follow-up visit	Change in Tear Lipid Layer Thickness (3mo follow-up - post-run-in baseline)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Research Center, School of Optometry, University of California, Berkeley; 🇺🇸 Berkeley, California, United States