Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product.
Subjects will be randomized to one of five different treatment sequences. Subjects will attend 6 scheduled visits with an expected individual duration of participation of 11 to 42 days. This study will be conducted in Australia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Other | NGF5-A/NGF4-B/NGF6-B/NGF6-E/Systane, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation |
|
| Sequence 2 | Other | NGF4-B/NGF6-B/NGF6-E/Systane/NGF5-A, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation |
|
| Sequence 3 | Other | NGF6-B/NGF6-E/Systane/NGF5-A/NGF4-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation |
|
| Sequence 4 | Other | NGF6-E/Systane/NGF5-A/NGF4-B/NGF6-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGF5-A test formulation | Other | One drop of investigational product instilled on the eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-Emergent Adverse Events (AEs) | An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). The number of adverse events as observed or reported will be recorded. | Up to Day 30 (Study Exit) |
| Number of Subjects with Biomicroscopy Findings Outside of Normal Limits | The cornea, conjunctiva, and eyelid will be assessed using a slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded. | Screening, up to Day 30 (Study Exit) |
| Mean Total Ocular Surface Staining Score | Ocular surface staining will be assessed using a slit lamp and recorded on a 15-point scale. | Screening, up to Day 30 (Study Exit) |
| Mean Best Corrected Visual Acuity (BCVA) | Visual Acuity will be assessed with correction in place using letter charts. BCVA will be measured in logarithm Minimum Angle of Resolution (logMAR). | Screening, up to Day 30 (Study Exit) |
| Number of Device Deficiencies | A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. The number of device deficiencies as observed or reported will be recorded. | Up to Day 30 (Study Exit) |
Not provided
Not provided
Key Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Dry Eye | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigator 8169 | Carlton | Victoria | 3053 | Australia | ||
| Alcon Investigator 8214 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sequence 5 | Other | Systane/NGF5-A/NGF4-B/NGF6-B/NGF6-E, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation |
|
| NGF4-B test formulation | Other | One drop of investigational product instilled on the eye |
|
| NGF6-B test formulation | Other | One drop of investigational product instilled on the eye |
|
| NGF6-E test formulation | Other | One drop of investigational product instilled on the eye |
|
| Systane eye drop | Other | One drop of commercial product instilled on the eye |
|
| Waurn Ponds |
| Victoria |
| 3216 |
| Australia |