Ophthalmic Safety-In-Use (Op SIU)

Ophthalmic Safety-in-Use

The objective of the Ophthalmic Safety-in-Use test is to determine the potential of a facial or eye area product to cause ocular irritation. This test is recommended for all cosmetic products and face creams that could potentially migrate into the eyes during application or normal wear. This study may be combined with a Dermal Safety-in-Use (Op/Derm SIU) for products such as foundations, moisturizers, sunscreens, etc. that are used on the entire face or for products such as shampoos or conditioners. For statistical relevance, it is recommended that no fewer than 30 subjects complete the study, which may include a subset of contact lens wearers and/or subjects who have self-perceived sensitive eyes. The duration of the study is usually four weeks but may be shorter or longer, depending on the product’s intended number of uses over the specified time period. Eurofins CRL technical staff can help advise on study design for your specific product.

Procedure

Individual units of the test product must be provided by you, the Sponsor, in a quantity sufficient to last each subject for the number of required uses. Eurofins CRL staff will label each unit with identifying study and subject numbers prior to distribution. At the baseline visit, each subject’s visual acuity will be checked and a slit lamp examination of the eyes will be performed to confirm the absence of inflammation of eyelids and conjunctivae and abnormalities of the corneas. Subjective irritation (reports of itching, burning, stinging, dryness and foreign body sensation) and degree of lacrimation will also be assessed. Derm Contact lenses will be observed for scratches, deposits and color. If applicable, facial skin will be evaluated for erythema, edema, and dryness. Qualified subjects are provided with the test products, instructions for use, and a daily diary in which to record each use. A final evaluation of visual acuity, changes in contact lenses, and subjective irritation as well as an examination of the eyes (and facial skin, if applicable) will be repeated following the required period of product use. If desired, a final questionnaire may be provided for completion by each subject in order to obtain consumer opinion of product attributes.

Interpretation & Reporting of Results

Following study completion, results of ocular and dermal evaluations as well as any reported Adverse Events will be reviewed by the Principal Investigator.    Generally, mild inflammation of the conjunctivae observed in a few subjects is not clinically significant and may be due to seasonal changes and/or current weather conditions. More pronounced inflammation or corneal abnormalities detected in multiple subjects and/or subjective reports of stinging, burning, itching, dryness or foreign body sensation may be indicative of irritation from the test product.

At the request of the Sponsor, unaudited topline results may be provided verbally or in writing approximately one to two weeks after study completion. An audited Final Report follows shortly thereafter.

Scheduling an Ophthalmic Safety-In-Use study

To schedule, please contact your Client Services representative at 732-981-1616 or contact Diane Dolgan at 732-393-5754 or by e-mail: diane.dolgan@crlresearchlabs.com.