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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Other: Propylene glycol-based eye drops

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 Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Castilla Y Leon
    • Valladolid, Castilla Y Leon, Spain, 47011
      • Investigative Site
• United Kingdom
  • London, United Kingdom, SW1E 6AU
    • Investigative Site
• United States
  • Missouri
    • Kansas City, Missouri, United States, 64133
      • Investigative Site
    • Kansas City, Missouri, United States, 64155
      • Investigative Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Other: Propylene glycol-based eye drops; Nano-emulsion ocular lubricant; Other Names: SYSTANE® Complete

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Alcon Pharmaceuticals, Alcon Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 18, 2018
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): May 14, 2019

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (ACTUAL): April 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: tear film; meibomian gland dysfunction; eye drops; evaporative dry eye; MGD; artificial tears; mixed dry eye; aqueous-deficient dry eye; lipid-deficient dry eye; lipid layer; eye symptoms; SYSTANE; SYSTANE Complete; nanoemulsion
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: CDMGD0012401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No