Testing of Ophthalmic Products – Contact Lenses and Contact Lens Care Products
The general principles for evaluating the potential of ophthalmic products that include contact lenses and contact lens care products to induce irritation to the human eye are carried out in accordance with a number of international and national standards and guidelines (e.g., ISO 9394, ISO 11979, ISO 18369, and ISO 10993). These standards include in vitro test methods that evaluate the potential cytotoxic effects that may arise due to interaction of contact lenses with contact lens care products, or the potential of contact lenses or a contact lens care solution to cause cytotoxicity by itself. Additional in vivo test methods include ocular safety assessment of both contact lenses and contact lens care products in rabbits.
Pacific BioLabs experienced team can provide guidance in developing a testing program that includes the test methods described above as well as additional test methods required by the FDA for ophthalmic product approval.