Inflammatory and mechanical complications associated with 3 years of up to 30 nights of continuous wear of lotrafilcon A silicone hydrogel lenses.
ABSTRACT 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.
Nineteen sites enrolled 317 subjects (286 current wearers and 31 new wearers), who were dispensed lotrafilcon A lenses with 3 years of follow-up.
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.
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.
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ABSTRACT: To compare the corneal topographical changes induced by two first and second generation silicone-hydrogel (SiH) contact lenses after 3 months of daily wear (DW). Prospective, consecutive case-series in which patients wore one of 3 different contact lenses (either the first generation SiH Focus Night & Day, the second generation SiH Acuvue Oasys or the monthly disposable Soflens 38 hydrogel lens as control group) on a DW basis for 3 months. Over-refraction, visual acuity, mean keratometry, corneal astigmatism, corneal eccentricity, superficial regularity and superficial asymmetry indices were monitored over the 3-month period. Nineteen eyes of 10 patients completed the study. Seven Focus Night & Day, 7 Acuvue Oasys and 5 Soflens 38 contact lenses were fitted. There were no significant changes between any of the parameters measured at the 3-month visit in any of the SiH groups (non-parametric Wilcoxon test, p>0.05). However, the control group (Soflens 38) showed statistically significant changes regarding mean keratometry, corneal astigmatism and corneal eccentricity (p<0.05). Three patients wearing the first generation SiH showed adverse events of different degree related to their high modulus of elasticity. After 3 months of DW, wearers of first and second generation SiH lenses showed greater corneal stability than hydrogel monthly disposable contact lenses users regarding commonly used topographic corneal shape indices. However, complications related to the mechanical properties of first generation SiH were seen in three patients in the follow-up time.Contact lens & anterior eye: the journal of the British Contact Lens Association 04/2009; 32(2):88-92. DOI:10.1016/j.clae.2008.11.002 · 2.00 Impact Factor
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ABSTRACT: Clinical studies that occur before and after the regulatory approval of contact lenses differ in many aspects, including breadth, length, and subject inclusion and exclusion criteria. A sample of published studies conducted in North America was reviewed to outline these differences and show their impact on rates of corneal complications with lenses. In postapproval studies of silicone hydrogel lenses, subject age and refractive error have been more diverse than in pre-approval trials, for example, 42% of lens wearers in a postapproval study of a single vision contact lens being older than 40 years. Inclusion of subjects in a wider age range in that study showed that lens wearers older than 50 years were at an increased risk for corneal infiltrates. Few adolescents were included in the first pre-approval trials of tisilfocon A overnight orthokeratology lenses, although many teenagers are prescribed the lenses in practice and may be at a higher risk for corneal infections with the device. The range of spectacle refractive error in a large postapproval registry of lotrafilcon A patients ranged from -16.00 to +7.00 diopters, significantly greater than that in pre-approval studies. A nonrandomized postapproval study showed that patient selection resulted in older patients with a higher degree of ametropia receiving silicone hydrogel lenses compared to younger patients with lower ametropia being fitted with hydrogel lenses. Postapproval studies give an organized view of the type of patients who will eventually make up the wearing population and their success or limitations with new types of contact lenses.Eye & Contact Lens Science & Clinical Practice 12/2007; 33(6 Pt 2):388-91; discussion 399-400. DOI:10.1097/ICL.0b013e318157d8b5 · 1.68 Impact Factor