Summary
Generally, contact lens products are sterile solutions or suspensions. Formulators for these products must have training in technologies practiced during development of sterile pharmaceutical products, such as injectable and large-volume IV fluids. The products must be effective and compatible with a wide range of lens materials. Components of the formulations should not accumulate in the lens or change the lens properties. They must be preserved adequately and be well tolerated by the sensitive ocular tissues. The products should also be simple to use to assure good compliance on the part of lens wearers. Additionally, they should be developed following the guidelines enumerated in Table 12.
Table 12 Types of Tests and Requirements Proposed by the FDA for Product Development
Chemistry/manufacturing
Solution/container descriptions Solution stability testing Lens group selection for solution testing Toxicology
Solution testing
Acute oral toxicity assessment Acute systemic toxicity assessment Acute ocular irritation and cytotoxicity assessment Sensitization/allergic response assessment Preservative uptake and release test Guinea pig maximization testing Container/accessory testing In vitro testing Systemic toxicity testing Primary ocular irritation testing Microbiology
Sterilization of the solution by the manufacturer Validation of the sterilization cycle USP sterility tests
USP-type preservative effectiveness test USP microbial limits test Shelf life-testing requirements Shelf life sterility
Shelf life preservative effectiveness Extension of shelf life protocol Disinfection of the lens
Chemical disinfection systems Contribution of elements test d-value determinations Multi-item microbial challenge test
Clinical
Patient characteristics
Number of eyes duration and number of investigators Initial patient visit parameters
Abbreviation: USP, United States Pharmacopoeia.
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