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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane Complete | Experimental | First dose of Systane Complete in both eyes on Day 0, followed by Systane Complete self-administered 4 times daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Complete | Other | Propylene glycol 0.6% eye drops for replenishing deficiencies in both the lipid and aqueous layers of the tear film |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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" |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Ocular Health | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigator 1455 | Kansas City | Missouri | 64111 | United States | ||
| Alcon Investigator 8046 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38079084 | Derived | 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. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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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 |
| Granville |
| Ohio |
| 43023 |
| United States |
| Alcon Investigator 6313 | Powell | Ohio | 43065 | United States |
| Alcon Investigator 8175 | Austin | Texas | 78731 | United States |