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The purpose of this post-market clinical follow-up (PMCF) study is to describe the effectiveness and safety of Tears Naturale® Free and Tears Naturale® II lubricant eye drops in subjects experiencing dry eye (DE) symptoms.
Each subject's participation will last approximately 30 days and include three scheduled visits: a screening/baseline clinic visit on Day 1 (Visit 1), a telephone follow-up visit on Day 15 (-2/+5 days) (Visit 2), and an in-office visit on Day 30 (-2/+5 days) (Visit 3).
This study will be conducted in Canada.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tears Naturale Free | Experimental | One to two drops of artificial tears per eye as needed for 30 days (-2/+5 days) |
|
| Tears Naturale II | Experimental | One to two drops of artificial tears per eye as needed for 30 days (-2/+5 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tears Naturale Free lubricating eye drops | Other | Commercially available, preservative free, artificial tear product containing dextran 70 and hypromellose. Artificial tear products are designed to relieve dryness and irritation by supplementing and stabilizing the tear film. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Impact of Dry Eye on Everyday Life - Symptom Bother Module (IDEEL - SB) Score | The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, the subject selected a single response for both eyes, where 0="None of the time" (Q1) or "I did not have this symptom/Not Applicable" (Q2-20) to 4="All of the time" (Q1) or "Very Much" (Q2-20). The overall Symptom Bother score is calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25, for an overall resultant score ranging from 0 to 100. Higher scores indicate greater symptom bother. | Screening/Baseline Visit (Day 1), Day 30 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alcon Call Center | Contact | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Dry Eye | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integra Eyecare Centre | Recruiting | Burnaby | British Columbia | V5E 1G3 | Canada | |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Tears Naturale II lubricating eye drops | Other | Commercially available, artificial tear product containing dextran 70 and hypromellose with a gentle preservative for multi-dose use. Artificial tear products are designed to relieve dryness and irritation by supplementing and stabilizing the tear film. |
|
| The Medical Arts Health Research Group |
| Recruiting |
| Kelowna |
| British Columbia |
| V1Y 4N7 |
| Canada |
| Eyes on Sheppard | Recruiting | North York | Ontario | M2N 3A1 | Canada |
| Dr. Shalu Pal & Associates | Recruiting | Toronto | Ontario | M5R 2A5 | Canada |
| Institut de L'Oeil des Laurentides | Recruiting | Boisbriand | Quebec | J7H 0E8 | Canada |
| Hopital de Chicoutimi and LASIK MD | Recruiting | Chicoutimi | Quebec | G7H 7W8 | Canada |