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.