Systane Hydration in Subjects Undergoing Cataract Surgery

Study Overview
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Brief Summary
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The primary objective of this study is to demonstrate reduced corneal staining with use of Systane Hydration among subjects with dry eye disease (DED) undergoing routine cataract removal and monofocal intraocular lens (IOL) implantation.

Detailed Description
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Subjects will attend 6 scheduled study visits for an individual duration of participation of 6 weeks. One eye (study eye) will be followed.

Official Title
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Systane Hydration in Subjects Undergoing Cataract Surgery

Conditions
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Dry Eye Disease, Cataract

Intervention / Treatment
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* Other: Systane Hydration lubricant eye drops


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Seeking routine (age-related) cataract extraction with monofocal intraocular lens implantation; Able to provide informed consent; Willing and able to attend all study visits and comply with treatment; Have dry eyes per dry eye questionnaire. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Subjects who use of ocular drugs, other than the test article (for treatment group only) and other standard of care postoperative medications, during the study; History of intraocular or corneal surgery in the study eye; Use of artificial tears, steroids, or other medications as specified in the protocol; Clinically significant corneal scarring; Corneal degeneration, retinal degeneration or other ocular pathology as specified in the protocol. 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Hydration<br>Systane Hydration lubricant eye drops dosed 4 times a day for 6 weeks (2 weeks prior to surgery and 4 weeks post surgery), with investigator defined post-operative standard of care | Other: Systane Hydration lubricant eye drops<br>* Sterile solution indicated for the temporary relief of burning and irritation due to dryness of the eye<br>* Other names: Systane Hydration® Ophthalmic Solution;|
| No Intervention: No Treatment<br>Investigator defined post-operative standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining | The National Eye Institute (NEI) grading scale will be used to evaluate the five corneal regions: Superior, inferior, central, temporal and nasal. Each region will be graded on a 0-3 scale, where 0 = normal (no staining), 1 = mild/superficial stippling micropunctate staining, 2 = moderate/macropunctate staining with some coalescent areas, and 3 = severe/numerous coalescent macropunctate areas and/or patches. The regions will be summed for a resultant overall score of 0 to 15. | Up to Day 30 post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DEQ-5 Score | The Dry Eye Questionnaire-5 (DEQ-5) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to 5 questions using a 0-4 Likert-type scale, for a resultant overall score of 0 (best) to 20 (worst). | Up to Day 30 post-operative | 
| Ocular Comfort Questionnaire Score: My eyes are comfortable | Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: My eyes are comfortable. | Up to Day 30 post-operative | 
| Ocular Comfort Questionnaire Score: At the end of the day, my eyes feel comfortable | Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: At the end of the day, my eyes feel comfortable. | Up to Day 30 post-operative | 
| Ocular Comfort Questionnaire Score: My eyes are comfortable all day long | Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: My eyes are comfortable all day long. | Up to Day 30 post-operative |