miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus

These are soft silicone hydrogel contact lenses (miafilcon A and B) in four variants: daily wear and daily disposable, each available in clear or color-enhancing versions. They correct refractive errors (myopia and hyperopia) in non-diseased eyes with minimal astigmatism (≤1.00D) and include UV-blocking capability.

Both miafilcon A (46% water content, Dk 155) and miafilcon B (48% water content, Dk 121) are spherical, cast-molded silicone hydrogels with comparable refractive indices (1.407 and 1.405 respectively), matching the predicate devices in diameter (13.0–15.0 mm), base curve (8.0–9.2 mm), and power range (-12.00D to +8.00D). The main difference is the lens material composition, though physical properties and oxygen permeability remain similar to predicates.

ISO 18369 (contact lens specifications), ISO 10993 series (biocompatibility: cytotoxicity, sensitization, acute toxicity, ocular irritation), and ISO 9394 (22-day rabbit contact lens wear study).

Although the lens material (miafilcon A and B copolymers) differs from the predicate (olifilcon A/B), non-clinical biocompatibility and physiochemical testing demonstrated acceptable safety profiles. Clinical studies in 192 subjects per arm showed no statistically significant differences versus predicates in adverse events, visual acuity, keratometry, or wear tolerance over 90 days. Both test and control groups achieved corrected visual acuity ≥1.0 with comparable safety endpoints, establishing functional and performance equivalence despite material differences.