Artificial Tears, Tear Lipids and Tear Film Dynamics

NCT05705518 | Completed Phase 4 Results FDA Drug

• 1 other identifier: CPHS_2022-09-15617
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dry Eye; Tear Film Lipid Layer Dynamics; Tear Film Stability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Tear Lipid Layer Uniformity

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

• Tear Film Thinning Rate

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

Other Outcomes (3)

• Exploratory - Subjective Symptoms - OSDI Questionnaire

  OSDI questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit

• Exploratory - Subjective Symptoms - SANDE

  SANDE questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit

• Exploratory - Subjective Symptoms - DEQ-5

  DEQ-5 questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit

Study Arms (4)

Systane Complete PF (Treatment)

EXPERIMENTAL

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

Refresh Relieva PF (Control)

PLACEBO COMPARATOR

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

Refresh Optive Mega-3 PF (Active Comparator 1)

ACTIVE COMPARATOR

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

CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)

ACTIVE COMPARATOR

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%)

Interventions

Systane Complete PF DRUG

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

Systane Complete PF (Treatment)

Refresh Relieva PF DRUG

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

Refresh Relieva PF (Control)

Refresh Optive Mega-3 PF DRUG

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

Refresh Optive Mega-3 PF (Active Comparator 1)

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

CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of California, Berkeley: lead
• Alcon Research: collaborator

Study Sites (1)

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

Berkeley, California, 94720-2020, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Andrew D. Graham
• Organization: University of California Berkeley Clinical Research Center

agraham@berkeley.edu

510-643-9252

Study Officials

• Meng C. Lin, OD, PhD

  University of California Berkeley Clinical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: After the 1-week initial period during which all subjects will use the run-in solution, subjects will be randomly assigned one of the 4 study solutions, and neither the subject nor the clinician researchers or technicians conducting examinations and taking measurements will be aware of which solution is assigned. All 4 solutions will be dispensed in color- and name-coded identical dispensing bottles prepared by study personnel not involved in collecting data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 30, 2023
• Study Start: January 30, 2023
• Primary Completion: September 30, 2023
• Study Completion: January 30, 2024
• Last Updated: March 14, 2025
• Results First Posted: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)