An interventional study of Systane Complete in Dry Eye Disease, sponsored by Alcon Research. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by Alcon Research · Not applicable, Interventional, and Treatment
The purpose of this study is to demonstrate effective symptom relief with the use of Systane Complete among subjects with dry eye disease (DED).
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.
This study's enrollment of 119 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
First dose of Systane Complete in both eyes on Day 0, followed by Systane Complete self-administered 4 times daily for 28 days
Other: Systane Complete
Propylene glycol 0.6% eye drops for replenishing deficiencies in both the lipid and aqueous layers of the tear film
Also known as: Systane® Complete Lubricant Eye Drops
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 0), Day 28
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Alcon Research