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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Propylene glycol-based eye drops
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SYSTANE Complete

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14
TFBUT will be assessed using fluorescein, an ocular staining dye

Secondary Outcome Measures

Change from baseline in dry eye symptom score at Day 1
As reported by the patient using a Likert scale post drop instillation
Soothing sensation score
As reported by the patient using a Likert scale post drop instillation
Tolerability assessment score
As reported by the patient using an assessment questionnaire post drop instillation
Change from baseline in ocular discomfort at Day 14
As reported by the patient using a Visual Analogue Scale (VAS)
Change from baseline in corneal staining score at Day 28
Assessment of ocular staining using staining dye under a slit lamp
Change from baseline in response to the revised IDEEL questionnaire at Day 28
As reported by the patient using a subjective questionnaire
Change from baseline in EQ-5D-5L score(s) at Day 28
As reported by the patient using a validated questionnaire
Change from baseline in TFBUT at Day 28
TFBUT will be assessed using fluorescein, an ocular staining dye

Full Information

First Posted
April 3, 2018
Last Updated
June 10, 2019
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03492541
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
May 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SYSTANE Complete
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Propylene glycol-based eye drops
Other Intervention Name(s)
SYSTANE® Complete
Intervention Description
Nano-emulsion ocular lubricant
Primary Outcome Measure Information:
Title
Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14
Description
TFBUT will be assessed using fluorescein, an ocular staining dye
Time Frame
Baseline, Day 14
Secondary Outcome Measure Information:
Title
Change from baseline in dry eye symptom score at Day 1
Description
As reported by the patient using a Likert scale post drop instillation
Time Frame
Baseline, Day 1
Title
Soothing sensation score
Description
As reported by the patient using a Likert scale post drop instillation
Time Frame
Day 1
Title
Tolerability assessment score
Description
As reported by the patient using an assessment questionnaire post drop instillation
Time Frame
Day 1
Title
Change from baseline in ocular discomfort at Day 14
Description
As reported by the patient using a Visual Analogue Scale (VAS)
Time Frame
Baseline, Day 14
Title
Change from baseline in corneal staining score at Day 28
Description
Assessment of ocular staining using staining dye under a slit lamp
Time Frame
Baseline, Day 28
Title
Change from baseline in response to the revised IDEEL questionnaire at Day 28
Description
As reported by the patient using a subjective questionnaire
Time Frame
Baseline, Day 28
Title
Change from baseline in EQ-5D-5L score(s) at Day 28
Description
As reported by the patient using a validated questionnaire
Time Frame
Baseline, Day 28
Title
Change from baseline in TFBUT at Day 28
Description
TFBUT will be assessed using fluorescein, an ocular staining dye
Time Frame
Baseline, Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon Pharmaceuticals
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64155
Country
United States
Facility Name
Investigative Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Investigative Site
City
Valladolid
State/Province
Castilla Y Leon
ZIP/Postal Code
47011
Country
Spain
Facility Name
Investigative Site
City
London
ZIP/Postal Code
SW1E 6AU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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