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The purpose of this study is to evaluate the clinical effectiveness and tolerability of SYSTANE® Complete in adult patients with dry eye disease. Fluorescein-stained tear film break-up time (TFBUT) will be evaluated as the primary objective.
Patients will attend 4 scheduled visits: Screening Visit (Day -7 to Day 0), Visit 1/Baseline Visit (Day 1), Visit 2 (Day 14) and Visit 3 (Day 28).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYSTANE Complete | Experimental | Propylene glycol-based eye drops, 1 drop in each eye twice a day (BID) (morning and evening) for 28 days. Patients can administer additional doses in between the scheduled daily doses as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propylene glycol-based eye drops | Other | Nano-emulsion ocular lubricant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Tear Film Break-up Time (TFBUT) at Day 14 | TFBUT will be assessed using fluorescein, an ocular staining dye | Baseline, Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in dry eye symptom score at Day 1 | As reported by the patient using a Likert scale post drop instillation | Baseline, Day 1 |
| Soothing sensation score | As reported by the patient using a Likert scale post drop instillation |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-specified inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Alcon Pharmaceuticals | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Kansas City | Missouri | 64133 | United States | ||
| Investigative Site |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| Day 1 |
| Tolerability assessment score | As reported by the patient using an assessment questionnaire post drop instillation | Day 1 |
| Change from baseline in ocular discomfort at Day 14 | As reported by the patient using a Visual Analogue Scale (VAS) | Baseline, Day 14 |
| Change from baseline in corneal staining score at Day 28 | Assessment of ocular staining using staining dye under a slit lamp | Baseline, Day 28 |
| Change from baseline in response to the revised IDEEL questionnaire at Day 28 | As reported by the patient using a subjective questionnaire | Baseline, Day 28 |
| Change from baseline in EQ-5D-5L score(s) at Day 28 | As reported by the patient using a validated questionnaire | Baseline, Day 28 |
| Change from baseline in TFBUT at Day 28 | TFBUT will be assessed using fluorescein, an ocular staining dye | Baseline, Day 28 |
| Kansas City |
| Missouri |
| 64155 |
| United States |
| Investigative Site | Norfolk | Virginia | 23502 | United States |
| Investigative Site | Valladolid | Castille and León | 47011 | Spain |
| Investigative Site | London | SW1E 6AU | United Kingdom |