Clinical benefits of a new multipurpose disinfecting solution in silicone
hydrogel and soft contact lens users.
Author(s): Campbell R, Kame G, Leach N, Paul M, White E, Zigler L.
Affiliation(s): Parkwood Eye Center, Elkin, NC, USA.
Publication date & source: 2012, Eye Contact Lens. , 38(2):93-101
OBJECTIVES: To evaluate the safety and efficacy of a new multipurpose
disinfecting solution (MPDS) containing a diblock copolymer,
poly(oxyethylene)-poly(oxybutylene), designed to improve the wetting properties
of silicone-hydrogel lenses.
METHODS: This 90-day, randomized, concurrently controlled, double-masked,
multisite study involved 573 subjects at 30 investigational sites in the United
states. Existing lens wearers were randomly assigned to either regimen 1
(OPTI-FREE PureMoist, a newly developed formulation, Alcon Laboratories Inc.,
Fort Worth, TX) or regimen 2 (renu fresh, Bausch and Lomb Inc., Rochester, NY).
At baseline, days 7, 30, 60, and 90, the subjects recorded subjective evaluations
relating to lens acceptability and comfort, wearing time, and rewetting drop
frequency, whereas investigators assessed slitlamp findings (including corneal
fluorescein staining), lens deposits (modified Rudko), visual acuity, and adverse
events. Group IV lenses were collected for ex vivo measurement of lysozyme
deposits.
RESULTS: Differences favoring regimen 1 were noted on day 90 for subjective
evaluations of lens comfort (insertion, removal, overall); lens moisture and
freshness; gentle on eye; clear vision; and lens handling (all P<0.004). Corneal
fluorescein staining severity and area and lysozyme deposits (group IV lenses)
were lower with regimen 1 (P<0.0001).
CONCLUSIONS: This 90-day study shows that the new MPDS designed for
silicone-hydrogel lenses is safe and effective when used by both
silicone-hydrogel and traditional soft lens wearers. By improving comfort and
decreasing lysozyme deposits and corneal fluorescein staining, the new MPDS
enhances patients' wearing experience and helps maintain optimal lens
performance.
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