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

Alcon Research134 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Dry Eye Disease

Interventions

Propylene glycol-based eye dropsOTHER

Nano-emulsion ocular lubricant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Investigative Site

Kansas City, Missouri, United States

Investigative Site

Kansas City, Missouri, United States

Investigative Site

Norfolk, Virginia, United States

Investigative Site

Valladolid, Castille and León, Spain

Outcomes

Primary Outcomes

Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14

TFBUT will be assessed using fluorescein, an ocular staining dye

Time frame: Baseline, Day 14

Secondary Outcomes

Change from baseline in dry eye symptom score at Day 1

As reported by the patient using a Likert scale post drop instillation

Time frame: Baseline, Day 1

Soothing sensation score

As reported by the patient using a Likert scale post drop instillation

Time frame: Day 1

Tolerability assessment score

As reported by the patient using an assessment questionnaire post drop instillation

Time frame: Day 1

Change from baseline in ocular discomfort at Day 14

As reported by the patient using a Visual Analogue Scale (VAS)

Time frame: Baseline, Day 14

Change from baseline in corneal staining score at Day 28

Assessment of ocular staining using staining dye under a slit lamp

Time frame: 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

Time frame: Baseline, Day 28

Change from baseline in EQ-5D-5L score(s) at Day 28

As reported by the patient using a validated questionnaire

Data from ClinicalTrials.gov

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