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

NCT03492541 | Completed

• 1 other identifier: CDMGD0012401
• Study Type: interventional
• Target: 134
• Locations: 3 countries
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change from baseline in dry eye symptom score at Day 1

  Baseline, Day 1

• Soothing sensation score

  Day 1

• Tolerability assessment score

  Day 1

• Change from baseline in ocular discomfort at Day 14

  Baseline, Day 14

• Change from baseline in corneal staining score at Day 28

  Baseline, Day 28

Study Arms (1)

SYSTANE Complete

EXPERIMENTAL

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

Interventions

Propylene glycol-based eye drops OTHER

Nano-emulsion ocular lubricant

Also known as: SYSTANE® Complete

SYSTANE Complete

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (5)

Investigative Site

Kansas City, Missouri, 64133, United States

Location

Investigative Site

Kansas City, Missouri, 64155, United States

Location

Investigative Site

Norfolk, Virginia, 23502, United States

Location

Investigative Site

Valladolid, Castille and León, 47011, Spain

Location

Investigative Site

London, SW1E 6AU, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Officials

• Alcon Pharmaceuticals

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 10, 2018
• Study Start: July 18, 2018
• Primary Completion: April 30, 2019
• Study Completion: May 14, 2019
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (3); ES (1)