Artificial Tears, Tear Lipids and Tear Film Dynamics

Dry Eye Clinical Trial

— AlconAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05705518
• Other study ID #: CPHS_2022-09-15617
• Status: Completed
• Phase: Phase 4
• Start date: January 30, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: February 2024
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes

Intervention

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

Locations

Country	Name	City	State
United States	Clinical Research Center, School of Optometry, University of California, Berkeley	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Berkeley	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory - Subjective Symptoms - OSDI	Change in Ocular Surface Disease Index (OSDI) score (3mo follow-up - post-run-in baseline)	OSDI questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
Other	Exploratory - Subjective Symptoms - SANDE	Change in Symptom Assessment questionnaire iN Dry Eye (SANDE) score (3mo follow-up - post-run-in baseline)	SANDE questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
Other	Exploratory - Subjective Symptoms - DEQ-5	Change in 5-Item Dry Eye Questionnaire (DEQ-5) score (3mo follow-up - post-run-in baseline)	DEQ-5 questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit
Primary	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	Tear Lipid Layer Uniformity	Change in Tear Lipid Layer Thickness Coefficient of Variation (3mo follow-up - post-run-in baseline)	Lipid Layer Uniformity measured once at post-run-in baseline and once at 3mo follow-up visit
Secondary	Tear Film Thinning Rate	Change in Tear Film Thinning rate (3mo follow-up - post-run-in baseline)	Tear Film Thinning Rate measured once at post-run-in baseline and once at 3mo follow-up visit