Subjective and Objective Performance of Systane Complete Multi-Dose PF Versus Walgreen's Lubricant Balance

Subjective and Objective Performance of Systane Complete Multi-Dose PF Versus Walgreen's Lubricant Balance

Single site, prospective, double-masked, randomized-controlled, two-arm study of the dry eye symptoms as well as corneal and conjunctival staining in subjects using 2 different eyedrops. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include patient questionnaire, tear-breakup time, and slit lamp exam.

Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

• Subjects who currently have mild to moderate symptoms of dry eye as defined by a screening SANDE score of 20-55 inclusive (equivalent to OSDI score of 12 -32).2
• Subjects between the ages of 18-65.
• Subjects willing to comply with the prescribed regimen and schedule of eye drops.
• Subjects willing to attend all study visits.
• Subjects willing to discontinue any current artificial tear use 24 hours prior to the baseline study visit.

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• Ocular anterior segment infection, inflammation, abnormality, or active disease.
• History of herpetic keratitis or ocular surgery.
• Recent (within 1 year) thermal meibomian gland expression procedure including Lipiflow, iLux, or TearCare.
• Recent (within 1 year) blepharitis debridement procedure including BlephEx.
• Screening SANDE score > 55 (equivalent to OSDI score of >32).2 This is indicative of a severe dry eye.
• Screening SANDE score < 20 (equivalent to OSDI score of <12).2 This is indicative of a clinically normal eye.
• Screening non-invasive TBUT < 2 seconds, or > 10 seconds.3
• Screening NaFl score < 3 (clinically normal eye) or > 10 (severe dry eye).4
• Pregnant or lactating.
• Current use of contact lenses.
• Any change in eye drop regimen, whether OTC or RX in the last 90 days.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.