Phase 4
N=81
Artificial Tears, Tear Lipids and Tear Film Dynamics
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT05705518 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Tear Lipid Layer Thickness — 0.72; -7.58; 2.06; 1.41 nm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Systane Complete PF (Drug); Refresh Relieva PF (Drug); Refresh Optive Mega-3 PF (Drug); CVS Health Lubricant Eye Drop (PG 0.6%) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Berkeley
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Lipid Layer Thickness |
0.72; -7.58; 2.06; 1.41 | — |
| SECONDARY Tear Lipid Layer Uniformity |
-0.15; -0.77; -0.01; -0.23 | — |
| SECONDARY Tear Film Thinning Rate |
0.33; 1.71; 0.02; 0.70 | — |
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.
Eligibility Criteria
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;
Data sourced from ClinicalTrials.gov (NCT05705518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.