The safety of cosmetic products is extremely important, as it constitutes a fundamental requirement for protecting public health, maintaining consumer confidence and complying with regulatory standards. When it comes to cosmetic products for use in the periocular area or that may eventually come into contact with the eyes, it is important to assess their ophthalmologic acceptability and their potential for eye irritation, in order to prove the product's safety in this area.
Clinical studies aimed at assessing safety in humans can be divided into two main groups: compatibility studies (maximized conditions) and acceptability studies (real conditions of use), such as the ophthalmologic acceptability test.
Ophthalmologic acceptability test
In the ophthalmologic acceptability test, the product must be used in accordance with the instructions on the label for the period and repetitions requested, with the aim of ascertaining the safety of the product under real conditions of use.
At the start of the study, an ophthalmological medical assessment is carried out to verify the absence of initial clinical signs incompatible with the inclusion in the study. After 21 ± 2 days of using the product, participants undergo a final medical assessment. These assessments are carried out by an ophthalmologist with recourse to a slit lamp, and the parameters evaluated include blepharitis, meibomitis, hyperemia, lacrimation, chemosis, pruritus and eczema. The ophthalmic acceptability of the investigational product is also determined through the sensations of discomfort reported by the study participants themselves.
This test allows certain safety claims to be substantiated, such as “Ophthalmologically tested” and “Safe for the eye area”.
"No more tears” test
The “No more tears” test is designed to assess the product's potential to cause tearing and eye irritation by instilling the investigational product into the eye. The product is previously diluted in water in predefined and controlled quantities by an ophthalmologist, and comparisons are made with a known control product. The target of these studies consists of rinse-off products. After exposure, sensory information is collected from the participants and clinical information from the ophthalmologist.
Through this test, it is possible to justify the claims “Ophthalmologically tested” and “Tear-free product”.
Safety tests on humans must be carried out in accordance with guidelines and standards for clinical trials, such as the ICH E6 (R2) Good clinical practice - Scientific guideline, an international ethical and scientific quality standard for the designing, conducting, recording and reporting trials that involve the participation of human beings, and the Declaration of Helsinki by the World Medical Association (WMA) establishes ethical principles for medical research involving human beings.
Prior to clinical studies, the product's irritation potential should be analyzed in in-vitro studies. A commonly used method for this purpose is the HET-CAM test (Hen's Egg Test - Chorioallantoic Membrane).
HET-CAM
The HET-CAM test involves applying the test product to the chorioallantoic membrane of an embryonated chicken egg. This membrane is highly vascularized, which makes it a sensitive model for detecting irritation. Any signs of irritation such as bleeding, coagulation and lysis of blood vessels are observed. The severity and onset of these reactions are assessed to determine the product's irritation potential.
Ophthalmic testing of cosmetic products, in compliance with legal and ethical requirements, represents a fundamental step towards guaranteeing safety and acceptability for consumers and contributes to the overall success and credibility of cosmetic brands.
Do you intend to perform any of these ophthalmological tests on your cosmetic products? Contact us!
Comentários