Back to resultsSystane Complete Multi-symptom Relief
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Systane Complete
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease focused on measuring Eye drops
Eligibility Criteria
Key Inclusion Criteria:
- Able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form.
- Willing and able to attend all study visits as required per protocol.
- Have dry eye symptoms as specified in the protocol.
- Willing to discontinue use of all habitual artificial tear supplements for the entire study duration.
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
- Ocular conditions as specified in the protocol.
- Contact lens use within one week prior to screening visit.
- Use of medications as specified in the protocol.
- Pregnant or breast feeding.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Alcon Investigator 1455
- Alcon Investigator 8046
- Alcon Investigator 6313
- Alcon Investigator 8175
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Systane Complete
Arm Description
First dose of Systane Complete in both eyes on Day 0, followed by Systane Complete self-administered 4 times daily for 28 days
Outcomes
Primary Outcome Measures
Change from Baseline at Day 28 in IDEEL-SB Question "Sore"
The Impact of Dry Eye on Everyday Life - Symptoms Bother (IDEEL-SB) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Sore Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Change from Baseline at Day 28 in IDEEL-SB Question "Stinging"
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Stinging Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Change from Baseline at Day 28 in IDEEL-SB Question "Burning"
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Burning Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Change from Baseline at Day 28 in IDEEL-SB Question "Tired Eyes"
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Tired Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Change from Baseline at Day 28 in DEQ-5 Question "Watery"
The Dry Eye Questionnaire-5 (DEQ-5) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to the question, "During a typical day in the past month, how often did your eyes look or feel excessively watery?" using a 0-4 Likert-type scale, where 0 = Never and 4 = Constantly. A negative change value will represent perceived improvement.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05056155
Brief Title
Systane Complete Multi-symptom Relief
Official Title
Systane Complete Multi-symptom Relief
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
March 25, 2022 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to demonstrate effective symptom relief with the use of Systane Complete among subjects with dry eye disease (DED).
Detailed Description
Subjects will be expected to attend a screening/baseline visit and one additional visit at Day 28 (± 2 days), with a telephone call visit conducted at Day 14 (± 2 days). Individual duration of subject participation will be approximately 28 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
Eye drops
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane Complete
Arm Type
Experimental
Arm Description
First dose of Systane Complete in both eyes on Day 0, followed by Systane Complete self-administered 4 times daily for 28 days
Intervention Type
Other
Intervention Name(s)
Systane Complete
Other Intervention Name(s)
Systane® Complete Lubricant Eye Drops
Intervention Description
Propylene glycol 0.6% eye drops for replenishing deficiencies in both the lipid and aqueous layers of the tear film
Primary Outcome Measure Information:
Title
Change from Baseline at Day 28 in IDEEL-SB Question "Sore"
Description
The Impact of Dry Eye on Everyday Life - Symptoms Bother (IDEEL-SB) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Sore Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Time Frame
Baseline (Day 0), Day 28
Title
Change from Baseline at Day 28 in IDEEL-SB Question "Stinging"
Description
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Stinging Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Time Frame
Baseline (Day 0), Day 28
Title
Change from Baseline at Day 28 in IDEEL-SB Question "Burning"
Description
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Burning Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Time Frame
Baseline (Day 0), Day 28
Title
Change from Baseline at Day 28 in IDEEL-SB Question "Tired Eyes"
Description
Subjects will respond to the question, "OVER THE LAST TWO WEEKS, how much did the following symptom bother you: Tired Eyes?" using a 0-4 Likert-type scale, where 0 = "I did not have this symptom/Not applicable" and 4 = Very Much. A negative change value will represent perceived improvement.
Time Frame
Baseline (Day 0), Day 28
Title
Change from Baseline at Day 28 in DEQ-5 Question "Watery"
Description
The Dry Eye Questionnaire-5 (DEQ-5) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to the question, "During a typical day in the past month, how often did your eyes look or feel excessively watery?" using a 0-4 Likert-type scale, where 0 = Never and 4 = Constantly. A negative change value will represent perceived improvement.
Time Frame
Baseline (Day 0), Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form.
Willing and able to attend all study visits as required per protocol.
Have dry eye symptoms as specified in the protocol.
Willing to discontinue use of all habitual artificial tear supplements for the entire study duration.
Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
Ocular conditions as specified in the protocol.
Contact lens use within one week prior to screening visit.
Use of medications as specified in the protocol.
Pregnant or breast feeding.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, Ocular Health
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigator 1455
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Alcon Investigator 8046
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
Alcon Investigator 6313
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Alcon Investigator 8175
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Systane Complete Multi-symptom Relief
We'll reach out to this number within 24 hrs