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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 70

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Walgreen's Lubricant Balance	Walgreen's Lubricant Balance	-
Systane Complete Multi-Dose PF	Systane Complete Multi-Dose PF	-

Primary Outcome Measures

Name	Time	Method
SANDE Questionnaire	Change from baseline to 2 weeks	The Symptom Assessment iN Dry Eye (SANDE) questionnaire. Subjects are asked to place an 'X' on the line to indicate both the frequency and severity of their dry eye symptoms. Each question is scored from 0 to 100. The scores for frequency and severity are used to calculate a total score, where Total Score = square.root\[Q1 \* Q2\]. Higher total score on the questionnaire indicates more frequent or severe dry eye symptoms.

Secondary Outcome Measures