|Regulatory reference:||Guidelines to Commission Regulation (EU) No 655/2013|
|Application field:||Eye contour cosmetics or products that require to confirm the compatibility with the periocular mucosa in normal usage conditions.|
|Description of the test:||An ophthalmology specialist will inspect the target area, and especially the eyelids, before the application using a fissure lamp, in order to confirm the absence of swelling, hyperemia, dryness or desquamation. The inspection also includes any alterations of the eyelashes. |
In the eye itself, the integrity of the cornea and conjunctiva, the absence of hyperemia, and signs of conjunctival or tarsal irritation are verified. Finally, the absence of qualitative and quantitative alterations in the tear film.
The specialist then evaluates and scores erythemal response, tearing, edema and dryness after the product has been used for 30 minutes, 2 days and 30 days to quantify possible alterations induced by the sample.
The volunteers also provide subjective evaluations of itching, burning, stinging or foreign body response feeling, and/or sight clouding, at the same endpoints, using the VAS (Visual Analogical Scale) score system.