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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Complete PF | Drug | 3 month use, 4 times daily, of Systane Complete PF, a lipid-based, preservative-free artificial tear product |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Lipid Layer Uniformity | 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. | Lipid Layer Uniformity measured once at post-run-in baseline and once at 3mo follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory - Subjective Symptoms - OSDI Questionnaire | 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. | OSDI questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meng C. Lin, OD, PhD | University of California Berkeley Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, School of Optometry, University of California, Berkeley | Berkeley | California | 94720-2020 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42415246 | Derived | Ding JE, Pradhan A, Ma DK, FazioLiu AJ, Chang SM, Graham AD, Leung DJ, Wu RS, Zhou Y, Svitova T, Yeh TN, Lin MC. Randomized comparison of lipid-containing and non-lipid-containing artificial tears on tear film dynamics over a 3-month period. Optom Vis Sci. 2026 Jul;103(7):e70084. doi: 10.1002/ovs2.70084. |
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De-identified data collected in this study may be shared upon request, at the discretion of the PI, for non-commercial research purposes.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1-week Run-in Period |
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| Post-run-in Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tear Lipid Layer Thickness | Change in Tear Lipid Layer Thickness (3mo follow-up - post-run-in baseline) | Posted | Mean | 95% Confidence Interval | nm | Lipid Layer Thickness measured once at post-run-in baseline and once at 3mo follow-up visit |
|
Adverse event data were recorded for each subject monthly for 8 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew D. Graham | University of California Berkeley Clinical Research Center | 510-643-9252 | agraham@berkeley.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2023 | Feb 14, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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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.
| Refresh Relieva PF | Drug | 3 month use, 4 times daily, of Refresh Relieva PF, a non-lipid-based, preservative-free artificial tear product |
|
| 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 |
|
| 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 |
|
| 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 |
| 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 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| Secondary | Tear Lipid Layer Uniformity | 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. | Posted | Mean | 95% Confidence Interval | Unitless | Lipid Layer Uniformity measured once at post-run-in baseline and once at 3mo follow-up visit |
|
|
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| Secondary | Tear Film Thinning Rate | Change in Tear Film Thinning rate (3mo follow-up - post-run-in baseline) | Posted | Mean | 95% Confidence Interval | % Area of Fluorescein Darkening / sec | Tear Film Thinning Rate measured once at post-run-in baseline and once at 3mo follow-up visit |
|
|
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| Other Pre-specified | Exploratory - Subjective Symptoms - OSDI Questionnaire | 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. | Posted | Mean | Standard Deviation | units on a scale | OSDI questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit |
|
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| Other Pre-specified | Exploratory - Subjective Symptoms - SANDE | Change in Symptom Assessment questionnaire iN Dry Eye (SANDE) score (3mo follow-up - post-run-in baseline) | The SANDE questionnaire was not administered to any subjects due to logistical issues. | Posted | SANDE questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit |
|
|
| Other Pre-specified | Exploratory - Subjective Symptoms - DEQ-5 | Change in 5-Item Dry Eye Questionnaire (DEQ-5) score (3mo follow-up - post-run-in baseline) | The DEQ-5 questionnaire was not administered to any subjects due to logistical issues. | Posted | DEQ-5 questionnaire administered once at post-run-in baseline and once at 3mo follow-up visit |
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | 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 | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | 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 | 0 | 21 | 0 | 21 | 0 | 21 |
| EG003 | 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 | 0 | 19 | 0 | 19 | 0 | 19 |
| EG004 | 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 | 0 | 23 | 0 | 23 | 0 | 23 |
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