Products such as baby baths or shampoos are formulated so that they are less irritating and usually less prone to produce a stinging or burning sensation if they were to get into the eyes.
The objective of an Eye Instillation study is to assess the eye irritation potential of a product in comparison to a marketed control product. The study evaluates the irritation potential of the test product in support of "Tear Free" and "Optometrist Approved" claims.
The study is conducted in 2 phases, a pilot study and a main study. The pilot study in 3 volunteers is carried out before the main study. If, in the opinion of the optometrist, the 3 volunteers tolerated the concentration of test product satisfactorily, then a further 12 subjects are tested. If irritation is observed, the sponsor is contacted and the concentration reviewed. The test product is then tested in a further 12 unique subjects to complete in 15 volunteers, per product.
The test product is applied to one eye and the control product applied to the alternate eye by washing the surface of the eye for approximately 5 seconds using an eye bath.
The subjects are reassessed at 5 min and 60 min post application by the optometrist.
Subjective assessments are conducted at 5 minutes and 60 minutes post-treatment by means of a Subjective Questionnaire. Subjects are questioned about "Stinging", "Warm/Burning" and "Itching" sensations.
Products are compared for Visual acuity, Tear prism height and Injection of Conjunctiva. Visual acuity, Tear prism height and Injection of Conjunctiva are compared from Baseline to each assessment time point, for each test product.
In addition, products such as Mascara, Eye Shadow and Eye creams can be tested in an eye study in support of "Opthalmologically Tested" claims. We can offer bespoke study design and protocols to support claims or match any specific marketing requirements.
Our expert team are here to discuss your specific needs, assist you with study method selection and guide you through the appropriate regulatory requirements.