Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant Eye Drops using total ocular surface staining scores in subjects with dry eye administering it either as a scheduled regimen or as-needed after 28 days of treatment.

Detailed Description
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This study consists of a 14-day Run-in Phase (between the Screening Visit and Baseline/Visit 1) and a Treatment Phase. During the Run-in Phase, subjects will discontinue current artificial tears and will be dispensed SYSTANE® ULTRA to be administered 1 drop in each eye as needed (PRN). Subjects who meet the re-evaluation criteria after the Run-in Phase will be randomized in a 1:2 manner to receive treatment with SYSTANE® ULTRA 4 times per day (QID) or PRN, respectively, for 28 days.

Official Title
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Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: SYSTANE® ULTRA Lubricant Eye Drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to attend all study visits. Use of BAK-free artificial tear drops on an as needed basis, at least once a week, for at least 3 months prior to Screening Visit (maximum use of 4 drops a day). At least one '8 hour waking period' per week during the run-in phase without using the provided artificial tear. Use provided artificial tear at least once a week during run-in phase. Willing to take study treatment as directed for the entire study and able to complete the study diaries as required. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Use of artificial tears, as specified in the protocol. Use of topical ocular medications, as specified in the protocol. Women of childbearing potential who are pregnant, breast feeding, plan to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study. Any hypersensitivity to the use of the study product formulations or an allergy to any ingredient(s) contained within product formulations. Ocular abnormalities, infection, or active inflammation (not associated with dry eye) as specified in the protocol. Ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months prior to Screening Visit. Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study. Contact lens use within 2 weeks prior to Screening Visit, and unwilling to avoid contact lens use during the course of the study. Other protocol-specified 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 Ultra QID<br>SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days | Drug: SYSTANE® ULTRA Lubricant Eye Drops<br> <br> * Other names: SYSTANE® ULTRA;|
| Active Comparator: Systane Ultra PRN<br>SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days | Drug: SYSTANE® ULTRA Lubricant Eye Drops<br> <br> * Other names: SYSTANE® ULTRA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28 | The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is Absent and 5 is Severe. The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses. | Baseline (Day 0), Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28 | The IDEEL SB module is a 20 question patient reported outcome questionnaire that assesses the subject's symptoms of dry eye. An overall resultant calculated score ranges from 0 to 100, with higher scores indicating greater symptom bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses. | Baseline (Day 0), Day 28 | 
| Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28 | The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use (Treatment Effectiveness and Treatment Inconvenience). A resultant overall 0-100 treatment satisfaction score was calculated separately for Treatment Effectiveness and Treatment Inconvenience, with higher scores indicating greater satisfaction and less treatment-related bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses. | Baseline (Day 0), Day 28 |