AlconAT: Artificial Tears, Tear Lipids and Tear Film Dynamics

Sponsor

University of California, Berkeley (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05705518

Collaborator

Alcon Research (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Systane Complete PF Drug: Refresh Relieva PF Drug: Refresh Optive Mega-3 PF Drug: CVS Health Lubricant Eye Drop (PG 0.6%)	Phase 4

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 the Control 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

After the 1-week run in period during which all subjects will use the Control 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.

Primary Purpose:

Treatment

Official Title:

Effects Of Artificial Tears on Tear Lipid Films and Tear Film Dynamics In Vivo

Anticipated Study Start Date :

Jan 30, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Systane Complete PF (Treatment) 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 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product
Placebo Comparator: Refresh Relieva PF (Control) 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 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product
Active Comparator: Refresh Optive Mega-3 PF (Active Comparator 1) 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 3 month use, 4 times daily, of Refresh Optive Mega-3 PF, a lipid-based, preservative-free artificial tear product
Active Comparator: CVS Health Lubricant Eye Drop (PG 0.6%) (Active Comparator 2) 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%) 3 month use, 4 times daily, of CVS Health Lubricant Eye Drop (PG 0.6%), a lipid-based, preserved artificial tear product

Outcome Measures

Primary Outcome Measures

Tear Lipid Layer Thickness [Lipid Layer Thickness measured once at post-run-in baseline and once at 3mo follow-up visit]
Change in Tear Lipid Layer Thickness (3mo follow-up - post-run-in baseline)

Secondary Outcome Measures

Tear Lipid Layer Uniformity [Lipid Layer Uniformity measured once at post-run-in baseline and once at 3mo follow-up visit]
Change in Tear Lipid Layer Thickness Coefficient of Variation (3mo follow-up - post-run-in baseline)
Tear Film Thinning Rate [Tear Film Thinning Rate measured once at post-run-in baseline and once at 3mo follow-up visit]
Change in Tear Film Thinning rate (3mo follow-up - post-run-in baseline)

Other Outcome Measures

Exploratory - Subjective Symptoms - OSDI [OSDI questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit]
Change in Ocular Surface Disease Index (OSDI) score (3mo follow-up - post-run-in baseline)
Exploratory - Subjective Symptoms - SANDE [SANDE questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit]
Change in Symptom Assessment questionnaire iN Dry Eye (SANDE) score (3mo follow-up - post-run-in baseline)
Exploratory - Subjective Symptoms - DEQ-5 [DEQ-5 questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit]
Change in 5-Item Dry Eye Questionnaire (DEQ-5) score (3mo follow-up - post-run-in baseline)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Center, School of Optometry, University of California, Berkeley	Berkeley	California	United States	94720-2020

Sponsors and Collaborators

University of California, Berkeley
Alcon Research

Investigators

Principal Investigator: Meng C. Lin, OD, PhD, University of California Berkeley Clinical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, Berkeley

ClinicalTrials.gov Identifier:

NCT05705518

Other Study ID Numbers:

CPHS_2022-09-15617

First Posted:

Jan 30, 2023

Last Update Posted:

Jan 30, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of California, Berkeley

Dry Eye, Tear Film Stability, Tear Lipid Layer Dynamics

Additional relevant MeSH terms:

Dry Eye Syndromes

Ophthalmic Solutions

Lubricant Eye Drops

Study Results

No Results Posted as of Jan 30, 2023