Search

Purpose: To assess the stability of dryness symptoms after refitting patients wearing low-Dk/t hydrogel contact lenses with high-Dk/t silicone hydrogel contact lenses and to determine whether early dryness symptoms were predictive of discontinuation in the 3-year study., Methods: Two hundred seventy-eight hydrogel lens wearers were refitted with lotrafilcon A silicone hydrogel contact lenses for continuous wear of up to 30 nights. Self-administered questionnaires at baseline, 1 week, and 3 years captured the frequency and intensity of dryness symptoms during the day and at the end of the day. One-week and 3-year responses were compared to baseline by a Bowker test of symmetry and median change in response with Wilcoxon signed rank test., Results: Frequency of during-the-day and end-of-day dryness decreased from baseline to 1 week and 3 years (during the day, frequency > or = "sometimes" 57.1% vs. 33.1% after 1 week and 58.5% vs. 28.8% after 3 years; end of day, 61.1% vs. 41.0% after 1 week and 64.0% vs. 35.9% after 3 years [P<0.0001 for all comparisons]). After refitting, the proportion of subjects with dryness symptoms was stable. After 1 week, the presence of frequency of at least "sometimes" and severity of at least "moderate" during-the-day and end-of-day dryness were significantly associated with study discontinuation (during-the-day frequency [P=0.007] and severity [P=0.017]; end-of-day frequency [P=0.002] and severity [P=0.003])., Conclusions: Dryness symptoms improved after 1 week of refitting with lotrafilcon A and remained stable through 3 years. The presence of dryness after 1 week was associated with discontinuation from contact lens wear. Refitting with silicone hydrogel lenses reduced the frequency and severity of dryness symptoms seen with hydrogel lens wear for many subjects.

Purpose: To report the ocular complications occurring during a 3-year clinical trial of subjects wearing lotrafilcon A silicone hydrogel lenses for up to 30 nights of continuous wear., Methods: Nineteen sites enrolled 317 subjects (286 current wearers and 31 new wearers), who were dispensed lotrafilcon A lenses with 3 years of follow-up., Results: By the 1-month visit, continuous wear of up to 30 nights was recommended for 87% of subjects. The 27 lens-related adverse events included 15 (2.4%) eyes in year 1, seven (1.3%) eyes in year 2, and five (0.8%) eyes in year 3. Lens-related inflammatory events involved 12 (1.9%) eyes in year 1 and five (0.8%) eyes each in years 2 and 3. One third of the inflammatory events occurred in the first 3 months. Mechanical events included two superior epithelial arcuate lesions and one case of bilateral contact lens papillary conjunctivitis in years 1 and 2. No subjects experienced microbial keratitis during the 3-year trial. Two subjects with events discontinued from the trial., Conclusions: These results show that the rate of contact lens adverse events occurring with lotrafilcon A is low in this cohort, with the highest likelihood occurring during the first 3 months of the study. There was a decrease in the rate of events during the later years of the study. Although clinicians should understand the likelihood of adverse inflammatory and mechanical events and their possible recurrence, the rate of these events may be lower in practice than previously reported.

Objective: To estimate the cumulative probability and risk factors for developing corneal infiltrates after up to 3 years of continuous wear (CW) with lotrafilcon A lenses., Methods: Patients were fitted with lotrafilcon A lenses and followed up for 3 years. The main outcome variable was the first occurrence of any infiltrative event in either eye. Cox proportional hazards regression was used to model the probability of developing infiltrates as a function of demographic and biomicroscopy findings., Results: A total of 317 patients participated in this study. The Kaplan-Meier unadjusted cumulative incidence of a corneal infiltrate after CW was 5.7% (95% confidence interval [CI], 3.0%-8.4%) at the end of 1 year, 8.5% (95% CI, 5.2%-11.9%) at the end of 2 years, and 10.3% (95% CI, 6.6%-13.9%) at the end of 3 years. Corneal staining and limbal redness present in the affected eye on a previous visit were significantly associated with the development of an infiltrative event (hazard ratios, 7.23 and 3.18; P<.001 and P = .02, respectively)., Conclusions: Corneal staining and limbal redness may predict the subsequent development of an infiltrative event among CW contact lens patients. The probability of remaining free of any corneal infiltrates at the end of 3 years of CW of contact lenses was 89.7% (95% CI, 86.1%-93.4%).

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 (P<0.001), 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 (P<0.02), 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 (P=0.007). 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.

Purpose: This study measured the impact of previous contact lens wearing schedule on the resolution of signs and contact lens-related symptoms among wearers of lotrafilcon A lenses., Methods: One hundred forty adapted low Dk daily wear (DW) and 140 adapted low Dk extended wear (EW) subjects were enrolled and examined for 1 year (overall study length is 3 years). All subjects wore lotrafilcon A lenses on a wearing schedule of up to 30 nights continuous wear with monthly replacement of lenses. Examinations were conducted at 1 week, 1, 6, and 12 months., Results: The former EW wearers presented at baseline with significantly higher conjunctival staining and epithelial microcysts (p < 0.05) and lower ocular surface symptoms of end of day dryness than the former DW wearers. There were no significant differences in other ocular signs at baseline for the former DW and EW wearers. After use of lotrafilcon A, clinical signs of limbal, conjunctival redness, and neovascularization were significantly better by the 1-week visit for both groups of wearers. Regardless of former wearing schedule, symptoms of dryness (during and at the end of the day) and photophobia were significantly better after 1 week of lotrafilcon A use. The frequency and severity of symptoms of dryness during the day improved significantly among former low Dk DW and EW wearers within 1 week as did severity of dryness during the day for the former DW wearers, in part as a result of their higher prevalence at baseline in the DW group. Subjects reported redness improved significantly by the 1-month visit., Conclusions: Continuous wear of high Dk silicone hydrogel lenses resulted in an improvement in ocular redness and neovascularization and dryness symptoms among subjects in this trial, regardless of their previous low Dk lens-wearing schedule. All improvements in signs and symptoms were sustained through 12 months.