Effect of Daily Contact Lens Cleaning on Ocular Adverse Events during Extended Wear.

PURPOSE: The purpose of the study was to assess what effect daily cleaning of contact lenses with a multipurpose disinfection solution (MPDS), during 30 nights extended wear, would have on contact lens-related adverse events. METHODS: This was a prospective, open-label, randomized, controlled, parallel-group, 3-month clinical study in which 193 participants were dispensed with lotrafilcon A silicone hydrogel lenses for a 30-day extended-wear schedule and with lenses replaced monthly. Participants were randomized to a control or test group. Test subjects were required to remove lenses daily after waking, clean them with the MPDS, and reinsert the lenses. Control subjects wore lenses without removal for 30 days extended wear. Handling-related lens contamination was assessed at the baseline visit. RESULTS: There was no significant difference between the test and control groups for the incidence of significant corneal infiltrative events (1.3 vs. 4.9%, p = 0.368), total corneal infiltrative events (2.6 vs. 4.9%, p = 0.682), or mechanical events (1.3 vs. 2.5%, p = 1.00). The test group had greater corneal staining (p < 0.047) and fewer mucin balls (p = 0.033). Handling-related lens contamination (unworn lenses) resulted in isolation of Gram-positive bacteria from 92.5% of test lenses compared with 87.5% of control lenses (p = 0.712). Gram-negative bacteria were isolated from 5% of test subjects compared with 2.5% of control subjects (p = 1.00). Fungus was isolated from 2.5% of subjects in both the test and control groups (p = 1.00). CONCLUSIONS: The intervention of daily morning cleaning of the lens surface with an MPDS during extended wear did not significantly influence the incidence of adverse events.

Effect of antibiotic drops on adverse events during extended lens wear.

PURPOSE: Overnight lens wear is associated with increased lens contamination and risk of developing a corneal infiltrate or infectious event. Antibacterial lenses have been proposed as a potential strategy for reducing lens contamination. A proof-of-principle study was conducted to investigate what effect control of potential pathogens, through the use of antibiotic eye drops, would have on the incidence of corneal infiltrative events (CIEs) and on the ocular microbiota and lens contamination. METHODS: This is a prospective, open-label, controlled, parallel-group, 1-month clinical study in which 241 subjects were dispensed with lotrafilcon A silicone hydrogel lenses for 30 days of continuous wear. Subjects were randomized into either test (moxifloxacin 0.5%) or control (rewetting solution) group. One drop was instilled into each eye on waking and before sleeping, while lenses were on-eye. Follow-ups were conducted after one night and 1 month. Lid margin swabs were taken at baseline and at 1 month and worn lenses were aseptically collected at 1 month. RESULTS: The incidence of CIEs was not significantly different between the test (2.6%) and control (3.9%) groups (p = 0.72). Microorganism levels from the test group swabs were significantly lower than those from the control group (p = 0.001). Gram-positive bacteria were less frequently recovered from lower lid swabs from the test group (39.6% vs. 66.0% [p < 0.001], test vs. control, respectively) or from contact lens samples (1.9% vs. 10.5% [p = 0.015], test vs. control, respectively), but there was no difference in gram-negative bacteria (GNB). Corneal infiltrative events were associated with higher levels of lens contamination (p = 0.014) and contamination of lenses with GNB (CIE: 7.3% vs. 0.6% [p = 0.029], GNB contamination vs. no GNB contamination, respectively). DISCUSSION: Twice-daily antibiotic instillation during continuous wear of lenses did not significantly influence the rate of inflammatory events. Corneal infiltrative events were associated with higher levels of lens contamination in general and with contamination by GNB specifically.

Contact lens case contamination during daily wear of silicone hydrogels.

PURPOSE: Contamination of contact lens cases has been associated with the production of adverse responses in the eye during contact lens wear. This study aimed to evaluate the contamination rate and types of microbes contaminating cases during use of contact lens disinfecting solutions and silicone hydrogel lenses. METHODS: Two hundred thirty-two participants were allocated to one or more groups. The participants wore one or more of three silicone hydrogel lenses and used one or more of four contact lens disinfecting solutions. Cases were collected after use for 1 month and sent for routine microbial testing. The rate of contamination of cases and the types of microbes contaminating cases were evaluated. RESULTS: Between 76 and 92% of all cases were contaminated. Use of different contact lenses did not affect contamination rate or the types of microbes isolated from cases. Use of AQuify (PHMB as disinfectant) was associated with the highest contamination rate (92%; p = 0.015) of cases for any microbe. Level and type of contamination with use of ClearCare (H2O2) was similar to use of PHMB (polyhexamethylene biguanide)- or Polyquat/Aldox-containing solutions. There was no difference in contamination rate of cases by fungi or Gram-positive bacteria, but for Gram-negative bacteria, use of Opti-Free Express (Polyquat and Aldox as disinfectants) resulted in a lower contamination rate (7% vs. 29 to 45%; p < 0.001). The average number of microbes contaminating a case was significantly less for Opti-Free Express (223 +/- 1357 cfu/case) compared with Opti-Free RepleniSH (Polyquat and Aldox as disinfectants; 63,244 +/- 140,630 cfu/case; p < 0.001), driven mostly by differences in numbers of Gram-negative bacteria, particularly contamination by Delftia acidovorans in cases exposed to Opti-Free RepleniSH. CONCLUSIONS: Different disinfecting solutions used during storage in cases result in different levels of contamination and contamination by different types of microbes. These differences are not simply because of the types of disinfectants used, suggesting that other excipients in, or formulation of, the solution affect contact lens storage case contamination.

Release of betaine and dexpanthenol from vitamin E modified silicone-hydrogel contact lenses.

PURPOSE: To develop a contact lens system that will control the release of an osmoprotectant and a moisturizing agent with the aim to reduce symptoms of ocular dryness. MATERIALS AND METHODS: Profiles of the release of osmoprotectant betaine and moisturizing agent dexpanthenol from senofilcon A and narafilcon B contact lenses were determined in vitro under sink conditions. Both types of lenses were also infused with vitamin E to increase the duration of drug release due to the formation of the vitamin E diffusion barriers in the lenses. The release profiles from vitamin E-infused lenses were compared with those from the control lenses. RESULTS: Both dexpanthenol and betaine are released from commercial silicone hydrogel lenses for only about 10 min. Vitamin E loadings into contact lenses at about 20-23% can increase the release times to about 10 h, which is about 60 times larger compared to the control unmodified lenses. CONCLUSIONS: Vitamin E-loaded silicone hydrogel contact lenses released betaine and dexpanthenol in a controlled fashion.

Contact lenses: optimal vision--sub-optimal carrier?

The development of silicone hydrogel contact lenses with high oxygen permeabilities is a major step forward in vision correction. This advance in contact lenses material technology provides breakthrough levels of oxygen to the cornea. However, there are still important issues yet to be addressed by researchers, practitioners, and industry. Factors such as adequate correction for all refractive errors, microbial keratitis, comfort, and suitable lens care and lens biocompatibility are discussed from the authors' perspective.