The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of SYSTANE® BALANCE on Non-Invasive Tear Film Break Up Time (NITFBUT) in Dry Eye Subjects With Lipid Deficiency Following 30 Days of Use

Conditions
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Dry Eye

Intervention / Treatment
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* Other: Propylene glycol 0.6% ocular emulsion
* Other: Sodium chloride 0.9% saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Read, sign, and date an information consent; Willing and able to follow instructions and maintain the appointment schedule; Best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed at Visit 1; Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1; Meet protocol-specified criteria for dry eye at Visit 1; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past six months; Current punctal occlusion of any type (e.g., collagen plugs, silicon plugs); History of intolerance or hypersensitivity to any component of the study medications; History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye; Use of any concomitant topical ocular medications during the study period; Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1; Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation; Unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1. Participation in an investigational drug or device study within 30 days of entering this study; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYSTANE® BALANCE<br>Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days | Other: Propylene glycol 0.6% ocular emulsion<br> <br> * Other names: SYSTANE® BALANCE;|
| Active Comparator: LARMABAK®<br>Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days | Other: Sodium chloride 0.9% saline solution<br> <br> * Other names: LARMABAK®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systane BALANCE, Dry eye, lipid deficiency, NITFBUT