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The purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.
Subjects will be expected to attend a screening visit followed by 6 additional study visits. The expected duration of subject participation is approximately 3 weeks. This study will be conducted in Australia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FID123300/FID123301/FID122505 | Other | FID123300 ocular lubricant in Period 1, followed by FID12330 ocular lubricant in Period 2, followed by FID122505 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period. |
|
| FID123301/FID122505/FID123300 | Other | FID123301 ocular lubricant in Period 1, followed by FID122505 ocular lubricant in Period 2, followed by FID123300 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period. |
|
| FID122505/FID123300/FID123301 | Other | FID122505 ocular lubricant in Period 1, followed by FID123300 ocular lubricant in Period 2, followed by FID123301 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID123300 ocular lubricant | Other | Investigational ocular lubricant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity (BCVA) with manifest refraction, at distance | BCVA will be collected for each eye individually and recorded in logarithm Minimum Angle of Resolution (logMAR) | Day 1, each wear period. A wear period is 1 day. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Dry Eye | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Street Eye Centre | Sydney | New South Wales | 2000 | Australia | ||
| Ophthalmic Trials Australia |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| FID123301 ocular lubricant | Other | Investigational ocular lubricant |
|
| FID122505 ocular lubricant | Other | Comparator ocular lubricant |
|
| Teneriffe |
| Queensland |
| 4005 |
| Australia |
| University of Melbourne, Department of Optometry and Vision Science | Carlton | Victoria | 3053 | Australia |