Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency
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|ClinicalTrials.gov Identifier: NCT01688726|
Recruitment Status : Completed
First Posted : September 20, 2012
Results First Posted : November 18, 2014
Last Update Posted : November 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndrome Lipid Deficiency||Other: SYSTANE® BALANCE eyedrops Other: Minims® Saline 0.9% eyedrops||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluation of SYSTANE® BALANCE on Conjunctival Staining (CS) Visual Performance (VP) and Tear Film Kinetics (TFK) in Dry Eye Subjects With Lipid Deficiency|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: SYSTANE BALANCE
SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month
|Other: SYSTANE® BALANCE eyedrops|
Active Comparator: Minims Saline
Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month
|Other: Minims® Saline 0.9% eyedrops|
- Mean Bulbar Conjunctival Staining [ Time Frame: Month 1 ]The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.
- High Contrast logMAR Time Controlled Visual Acuity (TCVA) [ Time Frame: Month 1 ]TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
- Non Invasive Tear Film Break-up-time (NIBUT) [ Time Frame: Month 1 ]NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688726
|Principal Investigator:||Michel Guillon, PhD, FCOptom, FAAO, CCTI||OTG Research & Consultancy|