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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 134
- Locations
- 5
- Primary Endpoint
- Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
SYSTANE Complete
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
Intervention: Propylene glycol-based eye drops (Other)
Outcomes
Primary Outcomes
Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14
Time Frame: Baseline, Day 14
TFBUT will be assessed using fluorescein, an ocular staining dye
Secondary Outcomes
- Change from baseline in ocular discomfort at Day 14(Baseline, Day 14)
- Change from baseline in EQ-5D-5L score(s) at Day 28(Baseline, Day 28)
- Tolerability assessment score(Day 1)
- Change from baseline in TFBUT at Day 28(Baseline, Day 28)
- Change from baseline in corneal staining score at Day 28(Baseline, Day 28)
- Change from baseline in dry eye symptom score at Day 1(Baseline, Day 1)
- Soothing sensation score(Day 1)
- Change from baseline in response to the revised IDEEL questionnaire at Day 28(Baseline, Day 28)