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Artificial Tears, Tear Lipids and Tear Film Dynamics

NCT05705518 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-03-14

Study results available
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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.

Conditions

  • Dry Eye

Interventions

DRUG

Systane Complete PF

3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product

DRUG

Refresh Relieva PF

3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product

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

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

Sponsors & Collaborators

Principal Investigators

  • Meng C. Lin, OD, PhD · University of California Berkeley Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2023-09-30
Completion
2024-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05705518 on ClinicalTrials.gov