Human Eye Clinical Trials

These safety tests prove that your ingredients are safe for use when in contact with human eyes or within the eye cavity notwithstanding whether the product is intended for direct or accidental eye contact.

Human Eye Direct Instillation:

This comprises a study of 12 healthy male and female subjects to assess the comparative eye irritation potential of 1 test article plus our standard controls.
Active Phase: The Consultant Ophthalmologist facilitates slit lamp assessments immediately before, during and after direct instillation of the test article. In this study we have two phases: phase 1 is the Rising Dose Tolerance Phase where we apply the product into one of the eyes at a very high dilution in a couple of subjects. If we don’t reach the cut-off grade in terms of conjunctiva irritation, where we look at the bulbar and palpebral parts of the conjunctiva, or in terms of cornea irritation, then we go to a higher dilution and we use a step-wise approach to the in-use concentration which is, typically for a shampoo, around 10% wt/vl (10% solid mass to liquid volume). Once we reach that, we proceed to phase 2 of the study and look at the in-use concentration vs the benchmark.

Human Eye Non-Instillation:

Ophthalmological testing via non-instillation requires a single-blind within-subject comparison study using 30 healthy subjects.
Active Phase: If the product is something that can cause mechanical damage, such as mascara, but is still used around the eye, we would implement a Human Eye Non-Instillation Test. Our Consultant Ophthalmologist exams at day 0, so we establish the pre-treatment eye health, and then again at the end date, and we look at the post-treatment eye health for any significant changes. Subjects will be given the test article, calendar and instruction sheet, to be used at home between examinations.