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AzTrials

Dry EyePhase 4AlconATNCT05705518

Artificial Tears, Tear Lipids and Tear Film Dynamics

A Phase 4 study testing Systane Complete PF, Refresh Relieva PF and Refresh Optive Mega-3 PF in people with Dry Eye, run by University of California, Berkeley at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dry Eye
What is being tested?
Systane Complete PF, Refresh Relieva PF and Refresh Optive Mega-3 PF
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
1 siteUnited States
Study dates
30 Jan 2023to 30 Jan 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Research Center, School of Optometry, University of California, Berkeley

    Berkeley, California, 94720-2020

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Dry Eye
Being tested
Systane Complete PF, Refresh Relieva PF, Refresh Optive Mega-3 PF, CVS Health Lubricant Eye Drop (PG 0.6%)
Keywords
Dry Eye, Tear Film Lipid Layer Dynamics, Tear Film Stability
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Systane Complete PFDrug

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

  • Refresh Relieva PFDrug

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

  • Refresh Optive Mega-3 PFDrug

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

  • CVS Health Lubricant Eye Drop (PG 0.6%)Drug

    3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product

Study groups in NCT05705518
Study groupRoleWhat they receive
Systane Complete PF (Treatment)ExperimentalMasked 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.
Receives: Drug: Systane Complete PF
Refresh Relieva PF (Control)Placebo comparatorMasked 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.
Receives: Drug: Refresh Relieva PF
Refresh Optive Mega-3 PF (Active Comparator 1)Active comparatorMasked 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.
Receives: Drug: Refresh Optive Mega-3 PF
CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)Active comparatorMasked 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.
Receives: Drug: CVS Health Lubricant Eye Drop (PG 0.6%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tear Lipid Layer Thickness

    Change in Tear Lipid Layer Thickness (3mo follow-up - post-run-in baseline)

    Measured: Lipid Layer Thickness measured once at post-run-in baseline and once at 3mo follow-up visit

Secondary outcomes (2)

  1. Tear Lipid Layer Uniformity

    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.

    Measured: Lipid Layer Uniformity measured once at post-run-in baseline and once at 3mo follow-up visit

  2. Tear Film Thinning Rate

    Change in Tear Film Thinning rate (3mo follow-up - post-run-in baseline)

    Measured: Tear Film Thinning Rate measured once at post-run-in baseline and once at 3mo follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2023
  2. Study start30 Jan 2023
  3. Primary completion30 Sep 2023
  4. Study completion30 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05705518
Sponsor's protocol ID
CPHS_2022-09-15617
Acronym
AlconAT
Status last verified
Mar 2025
First submitted
20 Jan 2023
Last updated
14 Mar 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: De-identified data collected in this study may be shared upon request, at the discretion of the PI, for non-commercial research purposes.

Publications

  • Ding JE, Pradhan A, Ma DK, FazioLiu AJ, Chang SM, Graham AD, Leung DJ, Wu RS, Zhou Y, Svitova T, Yeh TN, Lin MC. Randomized comparison of lipid-containing and non-lipid-containing artificial tears on tear film dynamics over a 3-month period. Optom Vis Sci. 2026 Jul;103(7):e70084. doi: 10.1002/ovs2.70084.

    PubMed 42415246

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Systane Complete PF, Refresh Relieva PF and Refresh Optive Mega-3 PF in people with Dry Eye, run by University of California, Berkeley at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tear Lipid Layer Thickness (time frame: Lipid Layer Thickness measured once at post-run-in baseline and once at 3mo follow-up visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05705518, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.

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