Jerome Ozkan

Interactions of lens care with silicone hydrogel lenses and effect on comfort.

Purpose. The purpose of this study was to investigate the effect of lens care products on short-term subjective and physiological performance silicone hydrogel lenses. Methods. Ten subjects wore either lotrafilcon B or galyfilcon A silicone hydrogel contact lenses soaked in a lens care product containing either Polyquad/Aldox or PHMB or control lenses inserted directly from the pack. Subjects wore the lenses for 6 h. Ocular comfort (graded on a 1 to 10 scale) and ocular physiology were assessed. Unworn but soaked lenses were analyzed for metrological changes, release of excipients into phosphate buffered saline, and changes to their surface chemical composition. Results. None of the lens metrology measures or clinically observed conjunctival or limbal redness changed. Corneal staining was significantly (p < 0.008) raised, albeit to low levels, after 6 h wear for either lens type when soaked in the PHMB solution compared with the control lens (lotrafilcon B 0.4 to 0.9 ± 0.7 to 0.4 vs. 0.1 to 0.4 ± 0.3 to 0.5; galyfilcon A 0.2 to 0.3 ± 0.2 to 0.4 vs. 0.0 ± 0.0). For lotrafilcon B lenses, there were decreases in comfort (p = 0.002), increases in burning/stinging (p = 0.002) after 1 h of wear, and increases in lens awareness on lens insertion (p = 0.0001) when soaked in PHMB. However, lotrafilcon B lenses soaked in Polyquad/Aldox showed increases in burning/stinging after 1 and 6 h (p < 0.008) of lens wear. For galyfilcon A lenses, most significant (p ≤ 0.002) changes to symptomatology occurred after soaking in Polyquad/Aldox solution. More PHMB was released from lotrafilcon B lenses, and more MPDS material was released from galyfilcon A lenses. The surface of galyfilcon A lenses changed but irrespective of lens solution type, whereas the changes to the lens surface was dependent on solution type for lotrafilcon B lenses. Conclusions. Lens care products can change corneal staining and comfort responses during wear. These changes may be associated with release of material soaked into lenses or changes to the lens surface composition.

Fimbrolide-coated antimicrobial lenses: their in vitro and in vivo effects.

Purpose. To examine the ability of contact lenses coated with fimbrolides, inhibitors of bacterial quorum sensing, to prevent microbial adhesion and their safety during short-term clinical assessment. Methods. A fimbrolide was covalently attached to commercially available high Dk contact lenses. Subsequently Pseudomonas aeruginosa, Staphylococcus aureus, Serratia marcescens, or Acanthamoeba sp. were added to the lenses and control uncoated contact lenses. Lenses plus microbes were incubated for 24 h, then washed thoroughly to remove non-adherent microbes. Lenses were macerated and resulting slurry plated onto agar plates. After appropriate incubation, the numbers of colony forming units of bacteria (or numbers of Acanthamoeba trophozoites measured using a hemocytometer) from fimbrolide-coated and uncoated lenses were examined. A Guinea Pig model of lens wear was used to assess the safety of lenses worn on a continuous basis for 1 month. In a separate study, 10 subjects wore fimbrolide-coated lenses for 24 h. The responses of the Guinea Pigs and human volunteers to the lenses were assessed by slit lamp examination. Results. The fimbrolides-coated lenses reduced the adhesion of all bacterial strains tested, with reductions occurring of between 67 and 92%. For Acanthamoeba a reduction of 70% was seen. There were no significant differences in ocular responses to fimbrolide-coated lenses compared with controls in either the 1 month animal model or overnight human trial. Conclusions. Fimbrolide-coated lenses show promise as an antibacterial and anti-acanthamoebal coating on contact lenses and appear to be safe when worn on the eye in an animal model.

Clinical appearance and microscopic analysis of mucin balls associated with contact lens wear.

Purpose The structure of mucin balls collected from silicone hydrogel contact lens wearers was examined to determine their nature. Methods Tears containing mucin balls were collected using a capillary tube. These were processed for light microscopic histochemistry, scanning electron microscopy, and electron microscopic elemental analysis. Mucin balls were also observed in vivo using confocal microscopy. Results Histology showed that the mucin balls were PAS positive, indicating that glycoproteins form a major component. Lipids and bacteria were not detected. Scanning electron microscopy did not show the surface to be smooth but revealed a variation in density across the surface. Elemental analysis was inconclusive. Conclusions Mucin balls are likely to be made from collapsed mucin and are unlikely to have been formed as a result of pearling around a silicon, lipid, or bacterial kernel.

Bacterial Adhesion to Unworn and Worn Silicone Hydrogel Lenses

Purpose. The objective of this study was to determine the bacterial adhesion to various silicone hydrogel lens materials and to determine whether lens wear modulated adhesion. Methods. Bacterial adhesion (total and viable cells) of Staphylococcus aureus (31, 38, and ATCC 6538) and Pseudomonas aeruginosa (6294, 6206, and GSU-3) to 10 commercially available different unworn and worn silicone hydrogel lenses was measured. Results of adhesion were correlated to polymer and surface properties of contact lenses. Results. S. aureus adhesion to unworn lenses ranged from 2.8 × 104 to 4.4 × 105 colony forming units per lens. The highest adhesion was to lotrafilcon A lenses, and the lowest adhesion was to asmofilcon A lenses. P. aeruginosa adhesion to unworn lenses ranged from 8.9 × 105 to 3.2 × 106 colony forming units per lens. The highest adhesion was to comfilcon A lenses, and the lowest adhesion was to asmofilcon A and balafilcon A lenses. Lens wear altered bacterial adhesion, but the effect was specific to lens and strain type. Adhesion of bacteria, regardless of genera/species or lens wear, was generally correlated with the hydrophobicity of the lens; the less hydrophobic the lens surface, the greater the adhesion. Conclusions. P. aeruginosa adhered in higher numbers to lenses in comparison with S. aureus strains, regardless of the lens type or lens wear. The effect of lens wear was specific to strain and lens. Hydrophobicity of the silicone hydrogel lens surface influenced the adhesion of bacterial cells.

Lubricant effects on low Dk and silicone hydrogel lens comfort.

Purpose. To investigate the influence of three lubricants of varying viscosity, on postinsertion and 6 h comfort with contact lens wear. Methods. Comfort and associated symptoms of dryness were assessed in 15 experienced contact lens wearers. Subjects wore a low Dk lens in one eye and a silicone hydrogel in the other and participated in four separate trials involving no lubricant (baseline), saline, and two commercially available lubricants of differing viscosity. The in-eye lubricants were used immediately following lens insertion and every 2 h postinsertion for a 6 h wear period. Results. Postlens insertion comfort was significantly better for both lens types when lubricants or saline were used compared with no lubricant use. After 6 h lens wear, comfort was influenced by lens type and not by in-eye lubricant or saline use. Also after 6 h lens wear, less dryness sensation was reported for silicone hydrogel lenses when using lubricants but not saline. Discussion. Although lubricant use does help reduce dryness symptoms with silicone hydrogel lens wear, there appears to be minimal longer-term benefit to comfort. Furthermore, increased lubricant viscosity did not lead to improved longer-term comfort.

Corneal erosions, bacterial contamination of contact lenses, and microbial keratitis.

Objectives: To estimate the rate of corneal erosion coupled with gram-negative bacterial contamination of contact lenses and compare this with the rate of microbial keratitis (MK) with contact lenses. Methods: The rate of corneal erosion and contact lens contamination by gram-negative bacteria were calculated from several prospective trials. These rates were used to calculate the theoretical rate of corneal erosion happening at the same time as wearing a contact lens contaminated with gram-negative bacteria. This theoretical rate was then compared with the rates of MK reported in various epidemiological and clinical trials. Results: Corneal erosions were more frequent during extended wear (0.6-2.6% of visits) compared with daily wear (0.01-0.05% of visits). No corneal erosions were observed for lenses worn on a daily disposable basis. Contamination rates for lenses worn on a daily disposable basis were the lowest (2.4%), whereas they were the highest for low Dk lenses worn on an extended wear basis (7.1%). The estimated rate of corneal erosions occurring at the same time as wearing lenses contaminated with gram-negative bacteria was the lowest during daily wear of low Dk lenses (1.56/10,000 [95% CI: 0.23-10.57]) and the highest during extended wear of high Dk lenses (38.55/10,000 [95% CI: 24.77-60.04]). These rates were similar in magnitude to the rates reported for MK of different hydrogel lenses worn on differing wear schedules. Conclusion: The coincidence of corneal erosions during lens wear with gram-negative bacterial contamination of lenses may account for the relative incidence of MK during lens wear with different lens materials and modes of use.

Biocompatibility of Antimicrobial Melimine Lenses: Rabbit and Human Studies

Purpose Covalent immobilization of antimicrobial peptide melimine onto contact lenses can produce broad-spectrum antimicrobial lenses. The purpose of this study was to investigate the performance of melimine-coated contact lenses in an animal model and human clinical trial. Methods Melimine was covalently attached onto the surface of contact lenses via EDC (1-ethyl-3-[3-dimethylaminopropyl] carbodiimide hydrochloride) coupling. A rabbit model of daily contralateral wear of lenses for 22 days was conducted to assess the lens safety. A prospective, randomized, double-masked, one-day human clinical trial was used to evaluate subjective responses and ocular physiology during contralateral wear of melimine-coated (test) and uncoated (control) lenses. Delayed reactions were monitored during follow-up visits after 1 and 4 weeks. Ex vivo retention of antimicrobial activity of worn lenses was assessed by reduction in numbers of viable Pseudomonas aeruginosa and Staphylococcus aureus. Results Melimine-coated lenses produced no ocular signs or symptoms that would indicate cytotoxicity during the lens wear of rabbits. No histological changes were found in rabbit corneas. During the human trial, no differences were observed in wettability, surface deposition, lens-fitting centration, movement, tightness, and corneal coverage between test and control lenses (p > 0.05). There were no significant differences in bulbar, limbal, or palpebral redness or conjunctival staining (p > 0.05). Mean corneal (extent, depth, and type) staining was higher for test lenses compared with that for control lenses (p < 0.05). There was no significant difference in subjective responses for lens comfort, dryness, and awareness (p > 0.05). No delayed reactions were associated with the test lenses. Worn test lenses retained more than 1.5 log inhibition against both bacterial types. Conclusions Melimine-coated contact lenses were worn safely by humans. However, they were associated with higher corneal staining. The melimine-coated lenses retained high antibacterial activity after wear.

Risk factors for corneal inflammatory and mechanical events with extended wear silicone hydrogel contact lenses.

Purpose. To identify risk factors for contact lens-related corneal inflammatory events and mechanical events in wearers of silicone hydrogel lenses on a 30-night extended wear (EW) schedule in India. Methods. An interventional study with 188 subjects wearing silicone hydrogel lenses bilaterally on a 30-night EW schedule. Subjects were dispensed with lenses and reviewed at scheduled visits up to 6 months of EW. Multivariate logistic regression, after adjusting for within subject correlation, was used to develop the statistical model. Results. Occupations in non-ideal environments were found to predispose a lens wearer to inflammatory events (p = 0.003). Wearers in the non-ideal group, who had varying degrees of exposure to ocular irritants in their work environment had highest incidence of inflammatory events (19.2%). Wearers in a controlled, ideal environment had lowest levels of events (3.3%). Students occupied a position between the two groups (9.3%). Inflammatory rate was higher among wearers with increased microbial contamination of lenses (p = 0.002). Wearers with an inflammatory event had mean colony forming unit of 1.97 log compared with mean colony forming unit of 1.45 log in group with no inflammatory event. Corneal vascularization was associated with the development of inflammatory events (p = 0.001) with 50% of wearers with vascularization experiencing events compared with 7.6% of subjects with no vascularization. Reduced lens movement was associated with inflammatory events with subjects more likely to develop inflammatory events compared with those wearers with optimal lens movement (p = 0.027). Conclusions. A multitude of factors, including environmental influences, lens contamination, ocular characteristics, and lens fit, contributes to the development of inflammatory events, information that is of clinical relevance to practitioners worldwide. Occupational environment was also a contributory factor, confirming that a duty of clinicians is to ascertain the nature of the work environment of lens wearers (and potential wearers) and to balance the needs of the wearer with the potential risks.

Lens parameter changes under in vitro and ex vivo conditions and their effect on the conjunctiva

PURPOSE To quantify changes in contact lens parameters induced by lens wear and determine whether these changes are associated with contact lens-induced conjunctival staining (CLICS). METHODS In vitro: Lens diameter, sag, edge shape, base curve of six contact lens brands (balafilcon, comfilcon, etafilcon, lotrafilcon B, omafilcon and senofilcon) measured at 21°C and 35°C (eye temperature). Ex vivo: Diameter of lenses collected from a prospective, randomised, contra-lateral, cross-over clinical trial from 36 subjects wearing all lens types for 1 week daily wear, measured in 35°C PBS after removal. Ocular surface was examined for lens-induced conjunctival staining by masked examiner. RESULTS In vitro: Changes in diameter and base curve outside ISO tolerance were found with etafilcon A and omafilcon A. Ex vivo: Comfilcon A and etafilcon A had greatest shrinkage in diameter (0.18mm) and base curve (0.11mm steeper) with temperature increase from 21°C to 35°C. Senofilcon A, lotrafilcon B and balafilcon A maintained most stable parameters between 21°C and 35°C. Changes in diameter and base curve from lens wear were not correlated with CLICS (p>0.49). Multivariate analysis showed significantly greater levels of lens induced staining were associated with lens modulus (p<0.001) and knife (p<0.001) and chisel (p<0.001) edge shapes. CONCLUSIONS Parameter changes induced by lens wear were associated with increasing temperature, but these changes in lens diameter and base curve did not induce CLICS. Modulus and edge shape were associated with increased CLICS. The susceptibility of etafilcon A and omafilcon A lenses to parameter changes might be related to their high water content.

Effect of Prophylactic Antibiotic Drops on Ocular Microbiota and Physiology during Silicone Hydrogel Lens Wear

Purpose. Bacterial contamination of the contact lens surface has been demonstrated to cause corneal infiltrative events. A reduction in the rate of bacterially driven corneal infiltrative events associated with lens wear is one of the major goals of the contact lens industry. There is a concern over the potential of any antimicrobial strategy that there will be unwanted changes to the ocular microbiota or the development of resistance to the antimicrobial. The aim of this study was to investigate the effect of prophylactic topical antibiotic instillation during continuous wear of silicone hydrogel lenses on the normal ocular microbiota, the throat microbiota, and the ocular physiology. Methods. Forty-two male subjects were dispensed with lotrafilcon A silicone hydrogel contact lenses for a 3-month, 30 night continuous wear, monthly replacement trial. Subjects were randomized into either tobramycin 0.3% (test) or saline (control) drop group. Two drops were instilled into each eye on waking and before sleep. At monthly visits, lenses were collected aseptically, and ocular and throat swabs were performed, followed by standard microbial recovery and identifications. Any corneal infiltrative event at scheduled or unscheduled visits was recorded. Results. Numbers of microbes recovered from eye swabs from the tobramycin (test) group were significantly lower than the control (p = 0.01). Gram-positive cocci were recovered less frequently from the test group (p = 0.001). There were no significant differences in the numbers and types of microbes recovered from lens samples, or the contamination rate of the lenses between the two groups. There were no changes in the numbers of fungi or bacteria from throat swabs. There was no evidence of changes to resistance profile of microbes in the throat. More eye swabs from the test group (68.5%) were culture-negative than swabs from control (46.5%; p = 0.002). The test group had less corneal staining superiorly (0.0 ± 0.0 vs. 0.3 ± 0.4; p = 0.025) but increased bulbar redness (2.2 ± 0.5 vs. 1.5 ± 0.4; p < 0.001) at the 3-month visit only, compared with control group. Conclusions. Overall, there appeared to be a minimal safety risk with 3-months prophylactic antibiotic drop use during continuous wear of silicone hydrogel lenses. Clinically, antibiotic drop use induced a mild to moderate increase in bulbar redness by the 3-month time-point. Antibiotic use reduced microbiota on lids but did not affect the microbiota of the throat or change resistance to tobramycin.