Study of Efficacy and Tolerability of SYSTANE Complete in Patients With Dry Eye Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical effectiveness and tolerability of SYSTANE® Complete in adult patients with dry eye disease. Fluorescein-stained tear film break-up time (TFBUT) will be evaluated as the primary objective.

Detailed Description
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Patients will attend 4 scheduled visits: Screening Visit (Day -7 to Day 0), Visit 1/Baseline Visit (Day 1), Visit 2 (Day 14) and Visit 3 (Day 28).

Official Title
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Evaluation of the Clinical Efficacy and Tolerability of SYSTANE Complete in Adult Patients With Dry Eye Disease Following Topical Ocular Use for 4 Weeks: A Multicenter Trial

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Other: Propylene glycol-based eye drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have TFBUT of ≤ 5 seconds in at least one eye at Screening visit. Must have best corrected visual acuity (BCVA) of ≥ 20/80 (or ≥ 55 letters score or ≥ 0.6 early treatment diabetic retinopathy study (ETDRS) log of the minimum angle of resolution (LogMAR) value) in both eyes at the Screening visit. Must be willing to discontinue use of all artificial tear supplements and use only the study product as directed for the entire study duration. Exclusion Criteria: History of hypersensitivity to the study drug or any of its excipients or to drugs of similar chemical classes. Use of any topical ocular medication preserved with benzalkonium chloride or other products known to be toxic to the tear film lipid layer within 1 month prior to the Screening visit. Other protocol-specified inclusion and 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>Propylene glycol-based eye drops, 1 drop in each eye twice a day (BID) (morning and evening) for 28 days. Patients can administer additional doses in between the scheduled daily doses as needed | Other: Propylene glycol-based eye drops<br>* Nano-emulsion ocular lubricant<br>* Other names: SYSTANE® Complete;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14 | TFBUT will be assessed using fluorescein, an ocular staining dye | Baseline, Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in dry eye symptom score at Day 1 | As reported by the patient using a Likert scale post drop instillation | Baseline, Day 1 | 
| Soothing sensation score | As reported by the patient using a Likert scale post drop instillation | Day 1 | 
| Tolerability assessment score | As reported by the patient using an assessment questionnaire post drop instillation | Day 1 | 
| Change from baseline in ocular discomfort at Day 14 | As reported by the patient using a Visual Analogue Scale (VAS) | Baseline, Day 14 | 
| Change from baseline in corneal staining score at Day 28 | Assessment of ocular staining using staining dye under a slit lamp | Baseline, Day 28 | 
| Change from baseline in response to the revised IDEEL questionnaire at Day 28 | As reported by the patient using a subjective questionnaire | Baseline, Day 28 | 
| Change from baseline in EQ-5D-5L score(s) at Day 28 | As reported by the patient using a validated questionnaire | Baseline, Day 28 | 
| Change from baseline in TFBUT at Day 28 | TFBUT will be assessed using fluorescein, an ocular staining dye | Baseline, Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mixed dry eye, aqueous-deficient dry eye, lipid-deficient dry eye, evaporative dry eye, tear film, eye drops, artificial tears, lipid layer, eye symptoms, meibomian gland dysfunction, MGD, SYSTANE, SYSTANE Complete, nanoemulsion