Wyniki długotrwałych badań klinicznych: porównanie trzyletniego okresu użytkowania silikonowo-hydrożelowych soczewek kontaktowych (lotrafilcon A) w trybie przedłużonym do 30 dni i nocy oraz soczewek hydrożelowych o niskiej tlenoprzepuszczalności noszony
Long-term Clinical Results: 3 Years of Up to 30-Night Continuous Wear of Lotrafilcon A Silicone Hydrogel and Daily Wear of Low-Dk/t Hydrogel Lenses
Peter Bergenske, O.D., Bill Long, B.S., Sally Dillehay, O.D., Ed. D, Joseph T. Barr, O.D., M.S., Peter Donshik, M.D., Glenda Secor, O.D., John Yoakum, O.D., Robin L. Chalmers, O.D.
Summary: Purpose. To summarize results of a 3-year clinical trial assessing subjective and objective experience with lotrafilcon A silicone hydrogel (SH) lenses for up to 30 nights of continuous wear or low-Dk/t daily-wear (LDW) hydrogel lenses. Methods. Nineteen sites dispensed SH lenses to 317 subjects (286 current wearers and 31 new wearers) and 2-week replacement LDW lenses to 81 new wearers in a 3-year study. Results. For the SH cohort, limbal redness, conjunctival redness, and corneal neovascularization improved among 23%, 21%, and 13% of eyes, respectively (P0.001), with no signs increasing significantly. For the LDW cohort, limbal redness, papillary conjunctivitis, and corneal staining increased among 11%, 21%, and 13% of eyes, respectively (P0.02), with no signs improving significantly. The change in average spherical equivalent power was -0.03 diopters for the age-matched SH cohort and -0.40 diopters for the LDW cohort (P0.007). During the 3 years, the SH group reported significantly less frequent dryness during and at the end of the day, redness, photophobia, lens awareness, and blurred vision. Significantly more LDW lens wearers reported frequent during-the-day and end-of-day dryness and blurred vision. Conclusions. During the 3 years, lotrafilcon A lens wearers who wore their lenses continuously for up to 30 nights showed stable, long-term improvements in many signs of corneal health and symptoms along with less myopic progression versus daily wearers of low-Dk/t hydrogel lenses. Many biomicroscopy signs and symptoms worsened among neophytes wearing daily-wear low-Dk/t hydrogel lenses. The use of lotrafilcon A lenses may minimize many ocular changes from soft contact lens wear.