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The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a day for 30 days to increase non-invasive tear film break up time over baseline, compared to a saline control, in dry eye subjects with lipid deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYSTANE® BALANCE | Experimental | Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days |
|
| LARMABAK® | Active Comparator | Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propylene glycol 0.6% ocular emulsion | Other |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in NITFBUT at Day 30 | NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers. | Baseline (Day 0), Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in NITFBUT at Day 14 | NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consultório Oftalmológico | Martínez | Buenos Aires | Argentina |
Of the 51 enrolled, 2 participants withdrew their consent prior to receiving treatment and were exited from the study. This reporting group includes all participants who received treatment.
Participants were recruited from 1 study center located in Argentina.
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| ID | Title | Description |
|---|---|---|
| FG000 | SYSTANE® BALANCE | Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days |
| FG001 | LARMABAK® | Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SYSTANE® BALANCE | Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days |
| BG001 | LARMABAK® | Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days |
| 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 | Mean Change From Baseline in NITFBUT at Day 30 | NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers. | Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit | Posted | Mean | Standard Deviation | seconds | Baseline (Day 0), Day 30 |
|
Adverse events were collected for the duration of the study (1 month, 3 days). An adverse event was defined as any untoward medical occurrence in a subject administered the test product, regardless of causal relationship.
This reporting group includes all participants who received at least one dose of Systane® BALANCE or saline solution.
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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 | SYSTANE® BALANCE | Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abayomi Ogundele, Pharm.D. | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019946 | Propylene Glycol |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Sodium chloride 0.9% saline solution |
| Other |
|
|
| Baseline (Day 0), Day 14 |
| Mean NITFBUT by Visit | NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers. | Baseline (Day 0), Day 14, Day 30 |
| Percent Change From Baseline in NITFBUT by Visit | NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers. | Baseline (Day 0), Day 14, Day 30 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| LARMABAK® |
Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days |
|
|
| Secondary | Mean Change From Baseline in NITFBUT at Day 14 | NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers. | Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit | Posted | Mean | Standard Deviation | seconds | Baseline (Day 0), Day 14 |
|
|
|
| Secondary | Mean NITFBUT by Visit | NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers. | Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit | Posted | Mean | Standard Deviation | seconds | Baseline (Day 0), Day 14, Day 30 |
|
|
|
| Secondary | Percent Change From Baseline in NITFBUT by Visit | NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers. | Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit | Posted | Mean | Standard Deviation | percent change | Baseline (Day 0), Day 14, Day 30 |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | LARMABAK® | Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days | 0 | 24 | 0 | 24 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Day 30 |
|