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The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified population of dry eye patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FID 114657 | Experimental | FID 114657 |
|
| Soothe XP Lubricant Eye Drops | Active Comparator | Soothe XP Lubricant Eye Drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID 114657 | Other | 1 drop both eyes four times a day for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Break-Up Time (TBUT) | measured at Days 0, 7, 14, 28 and 42 | |
| Corneal Staining | measured at Days 0, 7, 14, 28 and 42 | |
| Conjunctival Staining | measured at Days 0, 7, 14, 28 and 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Soothe XP Lubricant Eye Drops |
| Other |
1 drop both eyes four times a day for 6 weeks |
|