Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.

Official Title
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Evaluation of SYSTANE® BALANCE on Conjunctival Staining (CS) Visual Performance (VP) and Tear Film Kinetics (TFK) in Dry Eye Subjects With Lipid Deficiency

Conditions
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Dry Eye Syndrome, Lipid Deficiency

Intervention / Treatment
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* Other: SYSTANE® BALANCE eyedrops
* Other: Minims® Saline 0.9% eyedrops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-contact lens wearer; Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire; Lipid deficiency; Best visual acuity of 6/9 or better in each eye; Willingness to adhere to the instructions set in the clinical protocol; Signature of the subject informed consent form; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Use of systemic medication which might produce dry eye side effects; Systemic disease which might produce dry eye side effects; Active or recent ocular inflammation or infection; Use of ocular medication; Significant ocular anomaly; Previous ocular surgery; Previous use of Restasis; Any medical condition that might be prejudicial to the study; Pregnant or lactating; 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>SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month | Other: SYSTANE® BALANCE eyedrops<br> <br> |
| Active Comparator: Minims Saline<br>Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month | Other: Minims® Saline 0.9% eyedrops<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Bulbar Conjunctival Staining | 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. | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Contrast logMAR Time Controlled Visual Acuity (TCVA) | 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. | Month 1 | 
| Non Invasive Tear Film Break-up-time (NIBUT) | 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. | Month 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, Ocular surface, Vision complaint, Tear film stability, Time controlled functional visual acuity, Tear film kinetics