Systane Complete Multi-symptom Relief

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate effective symptom relief with the use of Systane Complete among subjects with dry eye disease (DED).

Detailed Description
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Subjects will be expected to attend a screening/baseline visit and one additional visit at Day 28 (± 2 days), with a telephone call visit conducted at Day 14 (± 2 days). Individual duration of subject participation will be approximately 28 days.

Official Title
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Systane Complete Multi-symptom Relief

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Other: Systane Complete


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form. Willing and able to attend all study visits as required per protocol. Have dry eye symptoms as specified in the protocol. Willing to discontinue use of all habitual artificial tear supplements for the entire study duration. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Ocular conditions as specified in the protocol. Contact lens use within one week prior to screening visit. Use of medications as specified in the protocol. Pregnant or breast feeding. 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Complete<br>First dose of Systane Complete in both eyes on Day 0, followed by Systane Complete self-administered 4 times daily for 28 days | Other: Systane Complete<br>* Propylene glycol 0.6% eye drops for replenishing deficiencies in both the lipid and aqueous layers of the tear film<br>* Other names: Systane® Complete Lubricant Eye Drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline at Day 28 in IDEEL-SB Question Sore | The Impact of Dry Eye on Everyday Life - Symptoms Bother (IDEEL-SB) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to the question, OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Sore Eyes? using a 0-4 Likert-type scale, where 0 = I did not have this symptom/Not applicable and 4 = Very Much. A negative change value will represent perceived improvement. | Baseline (Day 0), Day 28 | 
| Change from Baseline at Day 28 in IDEEL-SB Question Stinging | Subjects will respond to the question, OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Stinging Eyes? using a 0-4 Likert-type scale, where 0 = I did not have this symptom/Not applicable and 4 = Very Much. A negative change value will represent perceived improvement. | Baseline (Day 0), Day 28 | 
| Change from Baseline at Day 28 in IDEEL-SB Question Burning | Subjects will respond to the question, OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Burning Eyes? using a 0-4 Likert-type scale, where 0 = I did not have this symptom/Not applicable and 4 = Very Much. A negative change value will represent perceived improvement. | Baseline (Day 0), Day 28 | 
| Change from Baseline at Day 28 in IDEEL-SB Question Tired Eyes | Subjects will respond to the question, OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Tired Eyes? using a 0-4 Likert-type scale, where 0 = I did not have this symptom/Not applicable and 4 = Very Much. A negative change value will represent perceived improvement. | Baseline (Day 0), Day 28 | 
| Change from Baseline at Day 28 in DEQ-5 Question Watery | 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 the question, During a typical day in the past month, how often did your eyes look or feel excessively watery? using a 0-4 Likert-type scale, where 0 = Never and 4 = Constantly. A negative change value will represent perceived improvement. | Baseline (Day 0), Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye drops