Clinical trial NCT03492541: Study of Efficacy and Tolerability of SYSTANE Complete in Patients With Dry Eye Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
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
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-04-10
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14
timeFrame: Baseline, Day 14
Secondary outcomes:
measure: Change from baseline in dry eye symptom score at Day 1
timeFrame: Baseline, Day 1
measure: Soothing sensation score
timeFrame: Day 1
measure: Tolerability assessment score
timeFrame: Day 1
measure: Change from baseline in ocular discomfort at Day 14
timeFrame: Baseline, Day 14
measure: Change from baseline in corneal staining score at Day 28
timeFrame: Baseline, Day 28
measure: Change from baseline in response to the revised IDEEL questionnaire at Day 28
timeFrame: Baseline, Day 28
measure: Change from baseline in EQ-5D-5L score(s) at Day 28
timeFrame: Baseline, Day 28
measure: Change from baseline in TFBUT at Day 28
timeFrame: Baseline, Day 28
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Investigative Site
state: Missouri
city: Kansas City
country: United States
facility: Investigative Site
state: Missouri
city: Norfolk
country: United States
facility: Investigative Site
state: Virginia
city: Valladolid
country: Spain
facility: Investigative Site
state: Castilla Y Leon
city: London
country: United Kingdom
facility: Investigative Site
Study officials:
affiliation: Alcon Research
name: Alcon Pharmaceuticals
role: STUDY_DIRECTOR
References: