Consultório Oftalmológico
Martínez, Buenos Aires, Argentina
NCT Number: NCT01718028
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Martínez, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: SYSTANE® BALANCE
Other names: LARMABAK®
Time frame: Baseline (Day 0), 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.
Time frame: Baseline (Day 0), 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.
Time frame: Baseline (Day 0), Day 14, 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 longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.
Time frame: Baseline (Day 0), Day 14, 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. 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.
Alcon Research
Industry
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
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