Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
5% Tavilermide · 1 trial · 3 indications
The National Eye Institute (NEI) scale is a standardized grading system of 0-3 was used for each of the 5 areas on each cornea (central, superior, temporal, nasal, and inferior). Grade 0 was specified when no staining is present. The maximum score was 15.
The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm.
| Arm | Type | Description |
|---|---|---|
| 5% Tavilermide ophthalmic solution | EXPERIMENTAL | - |
| Vehicle ophthalmic solution | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 5% Tavilermide ophthalmic solution | DRUG | Twice a day topicial dosing |
| Vehicle ophthalmic solution | OTHER | Twice a day topical dosing |
Inclusion Criteria: * Subject-reported history of dry eye disease in both eyes for at least 6 months; * History of use of artificial tear eye drops for dry eye symptoms; * Total score of ≥40 on SANDE; * TFBUT; * Corneal fluorescein staining; * Lissamine green conjunctival staining; * Schirmer's tes...
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