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

March 3, 2025 updated by: University of California, Berkeley

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94720-2020
        • Clinical Research Center, School of Optometry, University of California, Berkeley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tear Lipid Layer Thickness
Time Frame: 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)
Lipid Layer Thickness measured once at post-run-in baseline and once at 3mo follow-up visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tear Film Thinning Rate
Time Frame: 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 Film Thinning Rate measured once at post-run-in baseline and once at 3mo follow-up visit
Tear Lipid Layer Uniformity
Time Frame: Lipid Layer Uniformity measured once at post-run-in baseline and once at 3mo follow-up visit
Change (3mo follow-up - post-run-in baseline) in Tear Lipid Layer Thickness Coefficient of Variation (CV). The CV is calculated as the standard deviation divided by the mean lipid layer thickness. A greater value of the CV indicates more variability in lipid layer thickness, a smaller value of the CV indicates a more uniformly thick lipid layer.
Lipid Layer Uniformity measured once at post-run-in baseline and once at 3mo follow-up visit

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory - Subjective Symptoms - SANDE
Time Frame: SANDE questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
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
Time Frame: DEQ-5 questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
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
Exploratory - Subjective Symptoms - OSDI Questionnaire
Time Frame: OSDI questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
Change (3mo follow-up - post-run-in baseline) in Ocular Surface Disease Index (OSDI) score. The OSDI questionnaire score ranges from 0-100, with higher scores indicating more severe symptoms of Dry Eye Disease.
OSDI questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Berkeley

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meng C. Lin, OD, PhD, University of California Berkeley Clinical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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