Clinical trial NCT05705518: Artificial Tears, Tear Lipids and Tear Film Dynamics
Official title: Effects Of Artificial Tears on Tear Lipid Films and Tear Film Dynamics In Vivo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Keywords: Dry Eye
Tear Film Lipid Layer Dynamics
Tear Film Stability
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2023-01-30
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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;

Primary outcomes:
measure: Tear Lipid Layer Thickness
timeFrame: Lipid Layer Thickness measured once at post-run-in baseline and once at 3mo follow-up visit
Secondary outcomes:
measure: Tear Lipid Layer Uniformity
timeFrame: Lipid Layer Uniformity measured once at post-run-in baseline and once at 3mo follow-up visit
measure: Tear Film Thinning Rate
timeFrame: Tear Film Thinning Rate measured once at post-run-in baseline and once at 3mo follow-up visit
Other outcomes:
measure: Exploratory - Subjective Symptoms - OSDI Questionnaire
timeFrame: OSDI questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
measure: Exploratory - Subjective Symptoms - SANDE
timeFrame: SANDE questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
measure: Exploratory - Subjective Symptoms - DEQ-5
timeFrame: DEQ-5 questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
Locations:
city: Berkeley
country: United States
facility: Clinical Research Center, School of Optometry, University of California, Berkeley
state: California
Study officials:
affiliation: University of California Berkeley Clinical Research Center
name: Meng C. Lin, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: