Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

Study Overview
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Brief Summary
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The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total ocular surface staining scores (TOSS) at Day 42.

Detailed Description
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Subjects will first be dispensed preservative-free 0.9% saline eye drops (saline eye drops) to be used during the Run-in phase between Screening Visit and Day 0 (Visit 1). Subjects who qualify will be randomized in a 1:1 manner to receive either treatment with SYSTANE® HYDRATION Lubricant Eye Drops or Hyabak 0.15% Eye Drops.

Official Title
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Evaluation of Clinical Outcomes Following the Use of SYSTANE® HYDRATION in Subjects With Dry Eye

Conditions
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Dry Eye

Intervention / Treatment
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* Device: SYSTANE HYDRATION lubricant eye drops
* Device: Hyabak 0.15% eye drops
* Drug: 0.9% saline 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 non-BAK (Benzalkonium Chloride) artificial tears at least once a day, for at least 3 months prior to Screening Visit; Diagnosis of Dry Eye (by a health care professional) for at least 3 months prior to Screening Visit; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Women of childbearing potential who are pregnant or breast feeding; Any hypersensitivity to the use of the study products or an allergy to any ingredient(s) contained within study products; Ocular abnormalities in either eye that could adversely affect the safety or efficacy outcome; Active ocular infection (bacterial, viral, or fungal) or active inflammation not associated with dry eye; Use of chronic systemic medications: (prescription, over the counter, vitamins/supplements) on a stable dose for less than 30 days prior to Screening Visit, or any anticipated change in dosing regimen during the course of the study; History of ocular or intraocular surgery or serious ocular trauma in either eye within 6 months prior to Screening Visit; Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of study products or safe participation in the study; Use of any topical ocular over-the-counter or prescribed medications in either eye (with the exception of artificial tears/gels/ lubricants) 2 weeks prior to Screening Visit; Contact lens use within 2 weeks prior to Screening Visit and unwilling to avoid contact lens use during the course of the study; Unwilling to avoid the use of additional artificial tears (other than the study products) throughout the study; 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYSTANE HYDRATION<br>SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days | Device: SYSTANE HYDRATION lubricant eye drops<br>* Preserved with POLYQUAD (polidronium chloride) 0.001%<br>* Other names: SYSTANE® HYDRATION;Drug: 0.9% saline eye drops<br>* Preservative-free, one drop 4 times a day in each eye (run-in period)<br>|
| Active Comparator: Hyabak 0.15%<br>Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days | Device: Hyabak 0.15% eye drops<br>* Preservative-free<br>* Other names: Hyabak 0.15%;Drug: 0.9% saline eye drops<br>* Preservative-free, one drop 4 times a day in each eye (run-in period)<br>|

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 42 | The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42 | The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother. | Baseline (Day 0), Day 42 | 
| Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42 | The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother. | Baseline (Day 0), Day 42 | 
| Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42 | TFBUT is defined as the time elapsed from the last blink until 1 or more dry spots appeared in the precorneal tear film. A longer tear film break-up time indicates a more stable tear film and may lead to improvement in dry eye symptoms. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Day 42 |