Trial Outcomes & Findings for Artificial Tears, Tear Lipids and Tear Film Dynamics (NCT NCT05705518)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

81 participants

Primary outcome timeframe

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

Results posted on

2025-03-14

Participant Flow

All subjects participated in a 1-week run-in period during which they used a common over-the-counter non-lipid artificial tear (Systane Ultra PF). Upon completion of the run-in period, participants were then randomized to one of the 4 study solutions.

Participant milestones

Participant milestones
Measure	Run-in Period Participants All subjects participate in a 1-week run-in period during which they used a common over-the-counter non-lipid artificial tear (Systane Ultra PF). Upon completion of the run-in period, participants will then be randomized to one of the 4 study solutions.	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. Systane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product	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. 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 (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. 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%) (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. 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
1-week Run-in Period STARTED	81	0	0	0	0
1-week Run-in Period COMPLETED	81	0	0	0	0
1-week Run-in Period NOT COMPLETED	0	0	0	0	0
Post-run-in Period STARTED	0	18	21	19	23
Post-run-in Period COMPLETED	0	18	21	19	23
Post-run-in Period NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Artificial Tears, Tear Lipids and Tear Film Dynamics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Systane Complete PF (Treatment) n=18 Participants 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. Systane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product	Refresh Relieva PF (Control) n=21 Participants 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. 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 (Active Comparator 1) n=19 Participants 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. 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%) (Active Comparator 2) n=23 Participants 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. 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	Total n=81 Participants Total of all reporting groups
Age, Continuous	36.3 years STANDARD_DEVIATION 16.1 • n=5 Participants	34.0 years STANDARD_DEVIATION 16.6 • n=7 Participants	38.4 years STANDARD_DEVIATION 17.1 • n=5 Participants	35.5 years STANDARD_DEVIATION 17.3 • n=4 Participants	36.0 years STANDARD_DEVIATION 16.6 • n=21 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants	16 Participants n=4 Participants	59 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	22 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity Group · Asian	10 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants	35 Participants n=21 Participants
Race/Ethnicity, Customized Race/Ethnicity Group · Non-Asian	8 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants	12 Participants n=4 Participants	46 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Systane Complete PF (Treatment) n=18 Participants 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. Systane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product	Refresh Relieva PF (Control) n=21 Participants 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. 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 (Active Comparator 1) n=19 Participants 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. 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%) (Active Comparator 2) n=23 Participants 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. 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
Tear Lipid Layer Thickness	0.72 nm Interval -2.48 to 3.93	-7.58 nm Interval -11.46 to -3.7	2.06 nm Interval -0.83 to 4.95	1.41 nm Interval -1.5 to 4.32

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Systane Complete PF (Treatment) n=18 Participants 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. Systane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product	Refresh Relieva PF (Control) n=21 Participants 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. 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 (Active Comparator 1) n=19 Participants 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. 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%) (Active Comparator 2) n=23 Participants 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. 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
Tear Lipid Layer Uniformity	-0.15 Unitless Interval -0.66 to 0.37	-0.77 Unitless Interval -1.47 to -0.06	-0.01 Unitless Interval -0.58 to 0.56	-0.23 Unitless Interval -0.7 to 0.24

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Systane Complete PF (Treatment) n=18 Participants 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. Systane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product	Refresh Relieva PF (Control) n=21 Participants 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. 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 (Active Comparator 1) n=19 Participants 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. 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%) (Active Comparator 2) n=23 Participants 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. 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
Tear Film Thinning Rate	0.33 % Area of Fluorescein Darkening / sec Interval -0.55 to 1.22	1.71 % Area of Fluorescein Darkening / sec Interval 1.04 to 2.38	0.02 % Area of Fluorescein Darkening / sec Interval -0.81 to 0.85	0.70 % Area of Fluorescein Darkening / sec Interval -0.13 to 1.53

OTHER_PRE_SPECIFIED outcome

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

Change (3mo follow-up - post-run-in baseline) in Ocular Surface Disease Index (OSDI) score. The OSDI questionnaire score ranges from 0-100, with higher scores indicating more severe symptoms of Dry Eye Disease.

Outcome measures

Outcome measures
Measure	Systane Complete PF (Treatment) n=18 Participants 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. Systane Complete PF: 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product	Refresh Relieva PF (Control) n=21 Participants 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. 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 (Active Comparator 1) n=19 Participants 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. 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%) (Active Comparator 2) n=23 Participants 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. 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
Exploratory - Subjective Symptoms - OSDI Questionnaire	2.88 units on a scale Standard Deviation 13.45	4.90 units on a scale Standard Deviation 16.31	2.79 units on a scale Standard Deviation 15.22	1.30 units on a scale Standard Deviation 9.48

OTHER_PRE_SPECIFIED outcome

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

Population: The SANDE questionnaire was not administered to any subjects due to logistical issues.

Change in Symptom Assessment questionnaire iN Dry Eye (SANDE) score (3mo follow-up - post-run-in baseline)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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

Population: The DEQ-5 questionnaire was not administered to any subjects due to logistical issues.

Change in 5-Item Dry Eye Questionnaire (DEQ-5) score (3mo follow-up - post-run-in baseline)