Systane Complete Multi-symptom Relief
1 other identifier
interventional
119
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2021
CompletedFirst Posted
Study publicly available on registry
September 24, 2021
CompletedStudy Start
First participant enrolled
November 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2022
CompletedMarch 29, 2022
March 1, 2022
5 months
September 15, 2021
March 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
Baseline (Day 0), Day 28
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.
Baseline (Day 0), Day 28
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.
Baseline (Day 0), Day 28
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.
Baseline (Day 0), Day 28
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.
Baseline (Day 0), Day 28
Study Arms (1)
Systane Complete
EXPERIMENTALFirst dose of Systane Complete in both eyes on Day 0, followed by Systane Complete self-administered 4 times daily for 28 days
Interventions
Propylene glycol 0.6% eye drops for replenishing deficiencies in both the lipid and aqueous layers of the tear film
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (4)
Alcon Investigator 1455
Kansas City, Missouri, 64111, United States
Alcon Investigator 8046
Granville, Ohio, 43023, United States
Alcon Investigator 6313
Powell, Ohio, 43065, United States
Alcon Investigator 8175
Austin, Texas, 78731, United States
Related Publications (1)
Bickle K, Miller JR, Tauber J, Awisi-Gyau D. Multi-symptom Relief with Propylene Glycol-Hydroxypropyl-Guar Nanoemulsion Lubricant Eye Drops in Subjects with Dry Eye Disease: A Post-Marketing Prospective Study. Ophthalmol Ther. 2024 Feb;13(2):481-494. doi: 10.1007/s40123-023-00853-3. Epub 2023 Dec 11.
PMID: 38079084DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, Ocular Health
Alcon Research, LLC
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
September 15, 2021
First Posted
September 24, 2021
Study Start
November 9, 2021
Primary Completion
March 25, 2022
Study Completion
March 25, 2022
Last Updated
March 29, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share