Clinical benefits of a new multipurpose disinfecting solution in silicone hydrogel and soft contact lens users.

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.

Clinical evaluation of silicone hydrogel lens wear with a new multipurpose disinfection care product.

PURPOSE: To evaluate subjective symptoms and clinical signs in silicone hydrogel contact lens wearers with three different multipurpose solution (MPS) lens care regimens. METHODS: In a double-masked, randomized, concurrently controlled study, 233 subjects from 12 clinical sites wore one of two silicone hydrogel lens brands (ACUVUE Advance or Focus NIGHT & DAY) for 1 month on a daily-wear basis supported by a new reconditioning multipurpose disinfecting solution (MPDS) preserved with POLYQUAD and ALDOX, regimen 1 (OPTI-FREE RepleniSH Multi-Purpose Disinfecting Solution), or by one of two MPSs preserved with polyhexamethyl biguanide, regimen 2 (ReNu MultiPlus Multi-Purpose Solution No Rub Formula) or regimen 3 (Complete MoisturePLUS Multi-Purpose Solution). RESULTS: Significant differences in favor of regimen 1 were found in subjective responses of subjects wearing ACUVUE Advance lenses. For Focus NIGHT & DAY lens wearers, regimen 1 was associated with significantly less corneal staining (severity [P=0.0019], area [P=0.0077]) than regimen 2 was. The average number of times per day that rewetting drops were used was significantly higher for subjects randomized to regimen 3 than for subjects using regimen 1. CONCLUSIONS: The clinical performance of the new MPDS product with silicone hydrogel lenses was generally as good as or better than the two comparative polyhexamethyl biguanide-preserved MPSs. Clinical differences were evident between the products. Practitioners should be aware that MPS product choice for use with silicone hydrogel lenses may lead to different clinical outcomes, particularly in regard to stress on the ocular surface, as evidenced by the corneal staining response.

Clinical performance of 'no rub' multi-purpose solutions.

This was a multi-site, 231-subject double-masked, bilateral crossover study to evaluate subjective comfort and satisfaction, corneal staining and lens deposits with two 'no rub' multi-purpose solutions (MPS) used with FDA Group II (alphafilcon A, SofLens 66, Bausch & Lomb) and Group IV (etafilcon A, SUREVUE, Johnson & Johnson Vision Care) soft contact lenses. Subjects used each of the two MPS, Regimen 1 (OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution No Rub Lasting Comfort Formula, Alcon Laboratories) and Regimen 2 (ReNu MultiPlus Multi-Purpose Solution, Bausch & Lomb), for 28 days. They wore the same lens type for the duration of the study and were evaluated on days 0, 14 and 28 of each treatment period. Subjective ratings of comfort and satisfaction were significantly different between regimens, with the majority of variables in favour of Regimen 1 (P < 0.05). Corneal staining was significantly greater with the Group II, Regimen 2 combination (P < 0.0001). Group IV lenses cared for with Regimen 1 had significantly less residual lysozyme on Day 28 (562 microg) than lenses cared for with Regimen 2 (1145 microg; P < 0.0001). While both products offer the convenience of a 'no rub' regimen, differences in performance should be considered when recommending these solutions to patients.