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Services >> Safety Clinical Trials >> Ophthalmic Safety-In-Use

Ophthalmic Safety-In-Use

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Ocular Safety with Ophthalmic Safety-In-Use (Op SIU) Testing

At Eurofins CRL, we understand the importance of ensuring the safety of cosmetic products, particularly those intended for use around the delicate eye area. Our Ophthalmic Safety-In-Use (Op SIU) test provides in-depth insights into the impact of your products, including eye cosmetics and hair care formulations, on ocular health. This crucial examination evaluates the potential of facial or eye area products to cause discomfort, irritation, or harm to the eyes, eyelids, and surrounding skin during application or daily use.

Essential for Eye Cosmetics and Eye-Contacting Products

Op SIU testing is particularly crucial for eye cosmetics and other cosmetic products that may come into contact with the eyes, as these formulations can potentially trigger allergic reactions, eyelid irritation, or eye infections. For a comprehensive analysis, Op SIU can be paired with Dermal Safety-in-Use (Op/Derm SIU) for products such as foundations, moisturizers, sunscreens, shampoos, or conditioners.

To ensure reliable and representative results, we recommend a study group of at least 30 subjects, including individuals who wear contact lenses and those with self-perceived sensitive eyes.

Rigorous Testing Procedure for Accurate Results

Our Op SIU testing process begins with the submission of individual units of your cosmetic products, which our team assigns with study and subject numbers. During the initial visit, subjects undergo visual acuity checks and comprehensive eye examinations to detect any pre-existing inflammation, abnormalities, allergic reactions, or eye infections. We also assess subjective irritation, lacrimation (tearing), and the conditions for wearers of contact lenses. Qualified subjects then receive the test products, along with detailed usage instructions and a daily diary to monitor each application.

After the designated product use period, a comprehensive evaluation is conducted, including visual acuity assessments, changes in contact lens condition, and subjective reports of irritation.

In-Depth Analysis and Comprehensive Reporting

All results undergo thorough examination by our Principal Investigator, focusing on ocular and dermal evaluations, and any reported adverse events, including potential reactions to the cosmetic products under evaluation.

While mild inflammation of the conjunctivae may be observed, it is typically not clinically significant. However, pronounced inflammation, corneal abnormalities, or subjective discomfort may indicate an adverse reaction to the test product, warranting further investigation.

Actionable Results for Product Optimization

For your convenience, preliminary topline results can be provided verbally or in writing about one to two weeks after the study's completion. A detailed, audited final report will follow shortly thereafter, providing actionable insights to guide product optimization and enhance safety, ensuring your formulations meet the highest standards of ocular safety.

Partner with Eurofins CRL and experience the confidence that comes with our comprehensive Ophthalmic Safety-In-Use (Op SIU) testing services, ensuring the ocular safety of your cosmetic products, and safeguarding the well-being of your customers.