Dry Eye Disease
Conditions
Keywords
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
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).
Interventions
OTHERPropylene glycol-based eye drops
Nano-emulsion ocular lubricant
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14 | Baseline, Day 14 | TFBUT will be assessed using fluorescein, an ocular staining dye |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Soothing sensation score | Day 1 | As reported by the patient using a Likert scale post drop instillation |
| Tolerability assessment score | Day 1 | As reported by the patient using an assessment questionnaire post drop instillation |
| Change from baseline in ocular discomfort at Day 14 | Baseline, Day 14 | As reported by the patient using a Visual Analogue Scale (VAS) |
| Change from baseline in dry eye symptom score at Day 1 | Baseline, Day 1 | As reported by the patient using a Likert scale post drop instillation |
| Change from baseline in response to the revised IDEEL questionnaire at Day 28 | Baseline, Day 28 | As reported by the patient using a subjective questionnaire |
| Change from baseline in EQ-5D-5L score(s) at Day 28 | Baseline, Day 28 | As reported by the patient using a validated questionnaire |
| Change from baseline in TFBUT at Day 28 | Baseline, Day 28 | TFBUT will be assessed using fluorescein, an ocular staining dye |
| Change from baseline in corneal staining score at Day 28 | Baseline, Day 28 | Assessment of ocular staining using staining dye under a slit lamp |
Countries
Spain, United Kingdom, United States
Outcome results
None listed