Bill Long

Risk Factors for Contact Lens Complications in US Clinical Practices

Purpose. To determine significant risk factors for any inflammatory and infectious events with soft contact lenses (SCL) in a large retrospective clinical chart review. Methods. Charts of patients who presented for SCL care from October 2005 through March 2006 were reviewed and observed for a potential of at least 2 years. Charts from those with office visits involving an event-requiring pharmacologic treatment and/or interruption of SCL wear were scanned and later adjudicated by a masked panel. Significant factors from a univariate analysis were included in a multivariate analysis for all events and subcategories of events separately. Overnight wear was not consistently recorded and was not analyzed. Results. Charts from 1276 SCL wearers comprised 4120 visits and 1454 years of SCL wear (2908 eye/yr) and included 306 events of interest in 228 patients. In a multivariate analysis, age <25 years was significantly associated with presenting any event, inflammatory events, and infectious events that may or may not be CL-related [incidence rate ratio (IRR) = 1.3; 95% CI, 1.0 to 1.7; 2.6X, 1.5 to 4.6; and 2.0X, 1.2 to 3.3, respectively]. Ametropia >5.00 D increased risk of any event (IRR = 1.5; 1.2 to 1.9) and for other infectious events (IRR = 1.9; 1.2 to 3.2). Use of daily disposable lenses associated with lid irritation (IRR = 4.5; 2.1 to 9.8) but was not significantly associated with any other type of events. New and hydrogel lens wearers had a lower incidence of all event types (IRR = 0.07; 0.01 to 0.46 and 0.77; 0.59 to 0.99, respectively). Conclusions. Eighty-two percent of these SCL wearers did not present with any complications during the observation period >2 years. The risk factors for inflammatory and infectious events among SCL wearers in clinical practice are similar to those reported in prospective clinical trials. High ametropia and age <25 years are the risk factors that impact the most types of events.

The stability of dryness symptoms after refitting with silicone hydrogel contact lenses over 3 years.

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 ≥ “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.

Impact of previous extended and daily wear schedules on signs and symptoms with high Dk lotrafilcon A lenses.

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.

Improving contact-lens related dryness symptoms with silicone hydrogel lenses.

Purpose. To determine dryness symptoms attributable to hydrogel contact lens (HCL) wear by comparing symptoms from age-matched HCL wearers and non-wearers in a cross-sectional study, and to compare that difference to the change in proportion of subjects reporting frequent dryness among HCL wearers after refitting with lotrafilcon A or B silicone hydrogels (SHCLs). Methods. Prevalence of frequent dryness symptoms was compared between HCL and non-wearers from a cross-sectional, historical dataset of Dry Eye/Contact Lens Dry Eye Questionnaires using an age-matched subset of 259 HCL and 246 non-wearers. Prospective change in prevalence of frequent dryness from non-randomized studies (n = 1036), in which daily wear (DW) HCL wearers were refit with lotrafilcon A or B SHCLs, was then compared to the cross-sectional difference between HCL wearers and non-wearers. Results. In the Dry Eye/Contact Lens Dry Eye Questionnaires dataset, 47% fewer non-wearers reported frequent dryness than HCL wearers (p = 0.0001). In the lotrafilcon A DW refitting trials, frequent dryness was reported by 67 and 62% fewer subjects for during the day (DD) and end of the day (EOD) dryness (p = 0.0001, both) after refitting. In continuous wear lotrafilcon A trials, there were 63 and 41% reductions in the proportion reporting frequent DD and EOD dryness (p = 0.014 and p = 0.02). Refitting to DW lotrafilcon B yielded a 48 and 46% reduction in the number of subjects reporting frequent DD and EOD dryness (p < 0.0001, both). Conclusions. After refitting DW HCL wearers with either lotrafilcon A or B SHCLs, the proportion of symptomatic wearers was approximately half; an amount similar to the difference in proportion between HCL and non-wearers. This raises the possibility that refitting HCL wearers with SHCLs eliminates the component of dryness that is induced by HCL wear. Further research with more robust experimental design is recommended to test this hypothesis.

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.

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.

The clinical performance of a silicone hydrogel lens for daily wear in an Asian population.

Purpose. To evaluate slitlamp findings, frequency and severity of symptoms, and wearing time with a silicone hydrogel contact lens when used for daily wear by patients of Asian ethnicity. Methods. This was a five-site, 88-patient, prospective, open-label study involving 1 month of daily wear of lotrafilcon A lenses (Focus NIGHT & DAY, CIBA Vision, Duluth, GA) among adapted soft lens wearers previously wearing etafilcon A (ACUVUE 2, Johnson & Johnson Vision Care, Jacksonville, FL) or polymacon (Optima FW, Bausch & Lomb, Rochester, NY) lenses. Results. Statistically significant improvements in conjunctival redness, limbal redness, and corneal neovascularization were reported after 1 week and 1 month of wear. Patients reported statistically significant improvements in subjective symptoms of redness, dryness during the day, and dryness at the end of the day. More patients reported increased than reduced average daily wear time and average daily comfortable wear time with the silicone hydrogel lens. Conclusions. Significant improvements in clinical signs and subjective symptoms may occur when some patients of Asian ethnicity wearing conventional hydrogel lenses for daily wear are refitted with silicone hydrogel lenses for daily wear.

Comfort-enhanced daily disposable contact lens reduces symptoms among weekly/monthly wear patients.

Objectives: The primary objective of this trial was to explore the extent to which common contact lens-related symptoms may be improved among symptomatic daily wear contact lens wearers who habitually replaced their lenses at intervals of 1 to 4 weeks when fitted with DAILIES AquaComfort Plus for daily disposable, daily wear. Primary variables were frequency and severity of tired eyes, irritated eyes, lens awareness, blurred vision, redness, discomfort, deposits, and dryness. Methods: Eight sites, investigators enrolled 83 subjects who reported two or more of the symptoms with frequency of often or always. A sample size estimate required 60 subjects for 80% power, two-sided &agr; = 0.05. Subjects were dispensed for 4 weeks of bilateral lens wear. Follow-up visits were at 2 and 4 weeks; data were collected by telephone surveys at 1 and 3 weeks. Results: Eighty-one subjects completed the trial. Statistically significant improvements in symptom frequency were found for the symptoms of tired eyes (P<0.001), irritated eyes (P<0.001), blurred vision (P<0.001), redness (P<0.001), discomfort (P=0.024), deposits/lens needs cleaning (P<0.001), and dryness (P<0.001). Statistically significant improvements in symptom severity were found for tired eyes (P<0.001), irritated eyes (P<0.001), blurred vision (P<0.001), redness (P<0.001), discomfort (P=0.037), deposits/lens needs cleaning (P<0.001), and dryness (P<0.001). Biomicroscopy signs of limbal redness, bulbar redness, and conjunctival staining showed statistically significant improvements at 2 weeks (P=0.02, 0.01, and 0.035) and 4 weeks (P≤0.001, 0.012, and 0.008). Conclusions: A range of common symptoms can be reduced and biomicroscopy signs can be improved with a comfort-enhanced daily disposable, daily wear lens, thus providing benefits that patients can experience and eye care practitioners can appreciate.

Safety of contact lenses in patients with diabetes.

The purpose of the present study was to determine if increased complications exist among patients with diabetes as compared with individuals without diabetes who wear soft disposable contact lenses for daily wear. Complications among daily-wear contact lens wearers who have worn soft contact lenses for 1 year or more were reported from a retrospective review of records. Eyes from 254 patients with diabetes and 254 individuals without diabetes (control), one eye for each subject, from six clinical practices were compared using chi2 and exact Wilcoxon analyses as appropriate. The overall incidence of complications was 49.8% among eyes of patients with diabetes and 48.0% among controls. The respective values for occurrence of corneal abrasions were 7.9% and 5.9%, those for corneal staining were 3.2% and 5.5%, and those for pain at some time while wearing a contact lens were 17% and 19.7%. No significant difference in complications, corneal abrasions, corneal staining, or experience of pain was found between daily-wear contact lens wearers with diabetes and controls. Thus patients with diabetes showed no increased complications over patients without diabetes for daily-wear soft contact lens wear.

Myopia progression during three years of soft contact lens wear.

Purpose. To analyze the effect of lens material alone on myopia progression in a multi-center non-randomized prospective study of daily wear hydrogel and continuous wear silicone hydrogel contact lenses. Methods. Refractive error data from completing subjects were collected during a 3-year study of 54 subjects wearing low-Dk/t hydrogel contact lenses for daily wear and 230 wearing silicone hydrogel contact lenses for up to 30 nights continuous wear. Univariate analysis of refractive error changes was first conducted on factors of lens type, age at baseline, and baseline refractive error. Multivariate analysis was then performed to control for potential confounders of age (categorical by decade and continuous), and baseline refractive error. Results. Multivariate analysis showed that refractive error changes were significantly affected by lens type (F = 78.2, p < 0.001, R2 = 0.218) and subject age (F = 131.2, p < 0.001, R2 = 0.319) but not baseline refractive error (F = 2.56, p = 0.11, R2 = 0.009). The model’s overall R2 value is 0.376; the age-adjusted refractive error changes are +0.02 D for the silicone hydrogel contact lens wearers and –0.41 D for the hydrogel contact lenses for the 3-year follow-up period. Conclusions. Subject age and lens type significantly influenced the degree of myopic progression, with younger subjects and low-Dk/t hydrogel contact lens wearers increasing more during the study. The Lotrafilcon A silicone hydrogel lens material may contribute to less myopia progression in adult contact lens wearers.

Clinical results comparing high-oxygen and low-oxygen permeable soft contact lenses in France.

Purpose. This article reports clinical results comparing a high-oxygen permeable (HDk) silicone hydrogel soft contact lens with a low-oxygen permeable (LDk) soft hydroxyethyl methacrylate contact lens when worn on an extended-wear basis. Methods. Six practitioners in France enrolled 134 subjects in this 4-month, open-label, multicenter, prospective, randomized, cross-over study. Subjects were randomized to receive either an HDk lotrafilcon A or an LDk etafilcon A soft contact lens. Subjects crossed over to the alternative lens after either 3 months’ experience with the HDk lens or 1 month’s experience with the LDk lens. Clinical and subjective data were collected at scheduled follow-up visits. Results. The subjective data has been reported in a separate article. Both types of lenses gave similar performance for visual acuity. Biomicroscopic examination findings averaged below grade 1 (trace) for both lenses throughout the study. A statistically significant difference for limbal redness was found at 1 week (HDk = 0.11; LDk = 0.33; paired-t test, P <0.05). Eight of 10 biomicroscopic signs improved within 1 week when subjects changed from the LDk lens to the HDk lens. Deposits for both lenses remained below grade 1, and wetting was nearly perfect for both lenses throughout the study. Over 90% of fittings for both lenses were acceptable or optimal. Conclusions. The improvements in biomicroscopy signs seen with the HDk lens may provide practitioners an alternative to LDk contact lenses for extended wear.