Artificial Tears, Tear Lipids and Tear Film Dynamics (AlconAT)

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Meng C. Lin, OD, PhD; Phone Number: 510-643-9252; Email: mlin@berkeley.edu
• Study Contact Backup: Name: Andrew D. Graham, MA; Phone Number: 415-418-4058; Email: agraham@berkeley.edu

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720-2020
      • Clinical Research Center, School of Optometry, University of California, Berkeley
      • Contact: Meng C. Lin, OD, PhD; Phone Number: 510-643-9252; Email: mlin@berkeley.edu
      • Contact: Andrew D. Graham, MA; Phone Number: 510-643-9252; Email: agraham@berkeley.edu
      • Principal Investigator: Meng C. Lin, OD, PhD
      • Sub-Investigator: Andrew D. Graham, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Systane Complete PF (Treatment); 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; 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product
Placebo Comparator: Refresh Relieva PF (Control); 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; 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product
Active Comparator: Refresh Optive Mega-3 PF (Active Comparator 1); 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; 3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product
Active Comparator: CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2); 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%); 3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory - Subjective Symptoms - OSDI	Change in Ocular Surface Disease Index (OSDI) score (3mo follow-up - post-run-in baseline)	OSDI questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
Exploratory - Subjective Symptoms - SANDE	Change in Symptom Assessment questionnaire iN Dry Eye (SANDE) score (3mo follow-up - post-run-in baseline)	SANDE questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
Exploratory - Subjective Symptoms - DEQ-5	Change in 5-Item Dry Eye Questionnaire (DEQ-5) score (3mo follow-up - post-run-in baseline)	DEQ-5 questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit

Collaborators and Investigators

• Sponsor: University of California, Berkeley
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Meng C. Lin, OD, PhD, University of California Berkeley Clinical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Dry Eye; Tear Film Stability; Tear Film Lipid Layer Dynamics
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: CPHS_2022-09-15617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data collected in this study may be shared upon request, at the discretion of the PI, for non-commercial research purposes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No