Solution-induced Corneal Staining Research Articles

Benchmarking evaluation of five PHMB-based multi-purpose solutions and a silicone hydrogel contact lens

AIM: To evaluate and compare the clinical performance of 5 kinds of polyhexamethylene biguanide (PHMB) based multi-purpose solutions (MPS) manufactured in China when used with a commercially available silicone hydrogel contact lens in terms of solution-induced corneal staining (SICS), ocular response (corneal staining and ocular hyperemia), corneal infiltrative event (CIEs) and ocular comfort. METHODS: This was a prospective, open label, randomized, parallel group clinical trial. Totally 162 participants (Pxs) who were at least 18y were enrolled and randomized into 5 groups of PHMB-based MPS made in China: Complete® MPS, Hydron® Aqua-shining moist, Baoshining™, Weicon® Fresh, Weicon® 2000 MPS (abbreviated as C, H, B, W, and W2). All participants wore balafilcon A contact lenses with monthly disposal (Bausch & Lomb Purevision®) in conjunction with the designated MPS on a daily wear for 3mo. Clinical visits were at baseline, 2wk, 1mo and 3mo. SICS and CIE were reported as first event incidence per 100 Px-months. Ocular response was graded on 0-4 scale in 0.5 steps (0=none, 4=severe) and ocular comfort was assessed via a numeric rating scale (1-10 in 1-point steps, 1=poor, 10=excellent). Ocular comfort and ocular response variables were analysed using linear mixed model. CIE and SICS were analysed using Fisher’s exact test and logistic regression. RESULTS: There were 36 (22%) Pxs who dropped out. SICS incidence for each MPS were: H (26.3%), B (20.8%), W (19.4%), W2 (13.4%), C (12.8%). The SICS rate of H was significantly different to W2 (P=0.012) and C (P=0.005). There were no significant differences in ocular response, CIE incidence and ocular comfort between different MPSs (P>0.05). Pxs with SICS had significantly lower comfort during the day and at the end of than those who did not have SICS. CONCLUSION: Differences in SICS incidence are found between MPSs but not for CIE incidence, ocular response or ocular comfort. SICS in PHMB-based MPS is found to be associated with ocular discomfort. More MPS/lens combinations should be studied in the future.

Cellular fluorescein hyperfluorescence is dynamin-dependent and increased by Tetronic 1107 treatment.

Sodium fluorescein ('fluorescein') staining of the ocular surface is frequently an indicator of compromised ocular health, and increases in the presence of certain contact lens multi-purpose solutions (MPS), a phenomenon known as solution induced corneal staining (SICS). The mechanism(s) underpinning fluorescein hyperfluorescence are uncertain, though may reflect increased cellular uptake of fluorescein by corneal epithelial cells. We have developed an in vitro model to study fluorescein uptake in both 'generic' mammalian cells (murine fibroblasts) and human corneal cells. Fluorescein hyperfluorescence increased after treatment with two MPS associated with clinical corneal fluorescein staining, yet there was no cellular hyperfluorescence for two MPS that do not cause this staining. Increased fluorescein uptake did not correlate with presence of a necrotic or an apoptotic marker (propidium iodide and caspase-3 respectively). Incubation of MPS-treated cells with dynasore (an inhibitor of dynamin, implicated in endocytic pathways) reduced fluorescein uptake irrespective of MPS treatment. The non-ionic surfactant Tetronic 1107 (present in both MPS associated with corneal fluorescein staining) increased uptake of fluorescein for both cell types, whereas an unrelated surfactant (Triton X-100) did not. We conclude that the clinical hyperfluorescence profile observed after exposure to four MPS can be reproduced using a simple model of cellular fluorescein uptake, suggesting this is the biological basis for SICS. Fluorescein entry does not correlate with necrosis or apoptosis, but instead involves a dynamin-dependent active process. Moreover the surfactant Tetronic 1107 appears to be a key MPS constituent triggering increased fluorescein entry, and may be the major factor responsible for SICS.

The impact of lens care solutions on corneal epithelial changes during daily silicone hydrogel contact lens wear as measured by in vivo confocal microscopy.

To assess corneal epithelial microstructure via confocal microscopy and determine if cellular changes are associated with lens care solutions during daily wear of silicone hydrogel contact lenses. Corneal in vivo confocal microscopy with the Nidek ConfoScan4 was performed at baseline and after 5 months of lotrafilcon A daily contact lens wear. Enrolled participants were randomized to use either a polyhexamethylene biguanide (PHMB) preserved multipurpose care solution (MPS) or a peroxide based solution system. Lens and storage case bioburden were assessed with aerobic culture methods. Univariate and multivariable analyses were done to evaluate the association between solution use, or solution-related clinical covariates, and morphologic differences (hyper-reflectivity) in the superficial epithelial cells and epithelial basal cell density. Data on 139 participants were available for analysis of superficial epithelial cells while data on 92 participants were available for epithelial basal cell density. Five months after randomization to the solution groups, 33% of participants had visible hyper-reflective cells. More participants using MPS had ≥1 hyper-reflective cells compared to peroxide users at 5 months (44% vs. 22%; p=0.006). Similarly at 5 months, more participants with solution-induced corneal staining (SICS) had ≥1 hyper-reflective cells compared to non-SICS participants (57% vs. 29%; p=0.010). The adjusted odds ratios (ORs) for risk of presenting with hyper-reflective cells in MPS users or SICS participants was 2.7 (95% CI; 1.27-5.65) and 3.4 (95% CI; 1.29-8.97), respectively. Basal cell density decreased by over 350 cells/mm2 over time (about 6%) in participants who had substantial bioburden on their lenses or in their storage case. The confocal microscope can detect epithelial cellular changes in vivo during contact lens wear. Hyper-reflective superficial epithelial cells are associated with a PHMB preserved solution and decreases in basal epithelial cell density may be associated with bacterial bioburden.

Pilot Study to Determine the Effect of Lens and Eye Rinsing on Solution-Induced Corneal Staining (SICS).

The main purpose of this study was to determine whether two interventions (rinsing the lens before lens insertion and rinsing the ocular surface post-lens removal) had any impact on solution-induced corneal staining (SICS). In addition, the presence of hyper-reflective epithelial cells in the presence of SICS was investigated. Twenty subjects wore new balafilcon A lenses, which had been soaked overnight in a multipurpose care product containing polyhexamethylene biguanide for 2 hours. The study was conducted across three phases. In phase 1 (investigator and subject masked, randomized eye), one lens was rinsed with nonpreserved saline before lens insertion. In phase 2 (investigator masked, randomized eye), one eye was rinsed with nonpreserved saline after lens removal, before staining assessment. Corneal staining was recorded as the percentage area of the cornea exhibiting superficial punctate staining. In both phases, ocular comfort and presence of specific symptoms were captured. In phase 3, there was no randomized treatment; confocal images of the epithelium were obtained after 2 hours of wear. In phase 1 (lens-rinse), there was no significant difference in staining between the treated and untreated eyes (84 vs. 92%, respectively; p = 0.06). In phase 2 (eye-rinse), there was also no significant difference between the treated and untreated eye (86 vs. 86%, p = 0.92). Most subjects were asymptomatic. In phase 3, images of hyper-reflective cells were captured in 97% of the eyes imaged. The two rinsing procedures did not affect the level of the SICS response. Hyper-reflective epithelial cells were found to be present in a significant number of eyes exhibiting SICS, and their presence warrants further investigation.

Clinical staining of the ocular surface: mechanisms and interpretations.

In this article we review the mechanism of ocular surface staining. Water-soluble dyes are excluded from the normal epithelium by tight junctions, the plasma membranes and the surface glycocalyx. Shed cells can take up dye. A proportion of normal corneas show sparse, scattered time-dependent, punctate fluorescein uptake, which, we hypothesise, is due to a graded loss of the glycocalyx barrier, permitting transcellular entry into pre-shed cells. In pathological staining, there is little evidence of 'micropooling' at sites of shedding and the term 'punctate erosion' may be a misnomer. It is more likely that the initial event involves transcellular dye entry and, in addition, diffusion across defective tight junctions. Different dye-staining characteristics probably reflect differences in molecular size and other physical properties of each dye, coupled with differences in visibility under the conditions of illumination used. This is most relevant to the rapid epithelial spread of fluorescein from sites of punctate staining, compared to the apparent confinement of dyes to staining cells with dyes such as lissamine green and rose bengal. We assume that fluorescein, with its lower molecular weight, spreads initially by a paracellular route and then by transcellular diffusion. Solution-Induced Corneal Staining (SICS), related to the use of certain contact lens care solutions, may have a different basis, involving the non-pathological uptake of cationic preservatives, such as biguanides, into epithelial membranes and secondary binding of the fluorescein anion. It is transient and may not imply corneal toxicity. Understanding the mechanism of staining is relevant to the standardisation of grading, to monitoring disease and to the conduct of clinical trials.

The Cellular Basis for Biocide-Induced Fluorescein Hyperfluorescence in Mammalian Cell Culture

Clinical examination of the ocular surface is commonly carried out after application of sodium fluorescein in both veterinary and medical practice by assessing the resulting ‘staining’. Although localized intensely stained regions of the cornea frequently occur after exposure to ‘adverse’ clinical stimuli, the cell biology underlying this staining is unknown, including whether intense fluorescein staining indicates the presence of damaged cells. Ocular exposure to certain contact lens multipurpose solutions (MPS) gives rise to intense fluorescein staining referred to as solution induced corneal staining (SICS), and we have made use of this phenomenon with Vero and L929 cell culture models to investigate the fundamental biology of fluorescein interactions with cells.We found that all cells take up fluorescein, however a sub-population internalize much higher levels, giving rise to brightly staining ‘hyperfluorescent’ cells within the treated cultures, which contain fluorescein throughout the cell cytoplasm and nucleus. The numbers of these hyperfluorescent cells are significantly increased after exposure to MPS associated with SICS. Surprisingly, hyperfluorescent cells did not show higher levels of staining with propidium iodide, a marker of lysed cells. Consistently, treatment with the cytolytic toxin benzalkonium chloride resulted in almost all cells staining with propidium iodide, and the complete abolition of fluorescein hyperfluorescence. Finally we found that internalization of fluorescein and its loss from treated cells both require cellular activity, as both processes were halted after incubation at 4°C.We conclude that fluorescein hyperfluorescence can be replicated in three diverse cell cultures, and is increased by MPS-treatment, as occurs clinically. The process involves the concentration of fluorescein by a sub-population of cells that are active, and does not occur in lysed cells. Our data suggest that corneal staining in the clinic reflects active living cells, and is not directly caused by dead cells being produced in response to adverse clinical stimuli.

Short-Term Clinical Comparison of Two Dual-Disinfection Multipurpose Disinfecting Solutions

To compare the short-term clinical performance of two dual-disinfectant multipurpose disinfecting solutions (MPDS) when used in conjunction with two silicone hydrogel contact lenses. Participants wore galyfilcon A and balafilcon A lenses, randomly allocated one type to each eye. Multipurpose disinfecting solutions were double-masked and allocated using a randomized crossover design. Lenses were presoaked overnight in the allocated MPDS, containing either polyquaternium-1/alexidine dihydrochloride (PQ-alexidine) or polyquaternium-1/myristamidopropyl dimethylamine (PQ-MAPDA). Lenses were worn daily for 4 days and disinfected with the same MPDS in which they had been soaked. Clinical assessments occurred immediately after insertion, 2 hours after insertion, and after 2 hours of wear on day 4. Subjective ratings were collected at each assessment and after 6 hours of wear on days 1 to 3. Linear mixed models were used for statistical analysis. Solution-induced corneal staining (SICS) incidence was significantly different between MPDS lens combinations (P=0.01) with PQ-MAPDA-balafilcon A showing the highest incidence (27.8%). The incidence of SICS was significantly higher when balafilcon A lenses were worn compared with galyfilcon A (19.4% vs. 2.8%; P=0.04). There was no significant difference in SICS incidence between MPDS (PQ-alexidine=5.6%, PQ-MAPDA=16.7%; P=0.08). Polyquaternium-1/alexidine dihydrochloride was associated with significantly fewer symptoms of burning/stinging (9.7±0.6 vs. 9.1±2.2; P=0.03) and self-assessed redness (9.8±0.5 vs. 9.2±1.9; P=0.03) on initial lens insertion. There were no significant differences between MPDS for comfort ratings (P>0.05). These short-term clinical results provide an initial indication that PQ-alexidine is associated with fewer symptoms on insertion but no significant difference in ocular comfort compared with PQ-MAPDA. Longer studies are required to provide further evidence.

Corneal Inflammatory Events with Daily Silicone Hydrogel Lens Wear

This study aimed to determine the probability and risk factors for developing a corneal inflammatory event (CIE) during daily wear of lotrafilcon A silicone hydrogel contact lenses. Eligible participants (n = 218) were fit with lotrafilcon A lenses for daily wear and followed up for 12 months. Participants were randomized to either a polyhexamethylene biguanide-preserved multipurpose solution or a one-step peroxide disinfection system. The main exposures of interest were bacterial contamination of lenses, cases, lid margins, and ocular surface. Kaplan-Meier (KM) plots were used to estimate the cumulative unadjusted probability of remaining free from a CIE, and multivariate Cox proportional hazards regression was used to model the hazard of experiencing a CIE. The KM unadjusted cumulative probability of remaining free from a CIE for both lens care groups combined was 92.3% (95% confidence interval [CI], 88.1 to 96.5%). There was one participant with microbial keratitis, five participants with asymptomatic infiltrates, and seven participants with contact lens peripheral ulcers, providing KM survival estimates of 92.8% (95% CI, 88.6 to 96.9%) and 98.1% (95% CI, 95.8 to 100.0%) for remaining free from noninfectious and symptomatic CIEs, respectively. The presence of substantial (>100 colony-forming units) coagulase-negative staphylococci bioburden on lid margins was associated with about a five-fold increased risk for the development of a CIE (p = 0.04). The probability of experiencing a CIE during daily wear of lotrafilcon A contact lenses is low, and symptomatic CIEs are rare. Patient factors, such as high levels of bacterial bioburden on lid margins, contribute to the development of noninfectious CIEs during daily wear of silicone hydrogel lenses.

Human Corneal Epithelial Cell Shedding and Fluorescein Staining in Response to Silicone Hydrogel Lenses and Contact Lens Disinfecting Solutions

Purpose: A pilot study was conducted to evaluate human corneal epithelial cell shedding in response to wearing a silicone hydrogel contact lens/solution combination inducing corneal staining. The nature of ex vivo collected cells staining with fluorescein was also examined.Methods: A contralateral eye study was conducted in which up to eight participants were unilaterally exposed to a multipurpose contact lens solution/silicone hydrogel lens combination previously shown to induce corneal staining (renu® fresh™ and balafilcon A; test eye), with the other eye using a combination of balafilcon A soaked in a hydrogen peroxide care system (Clear Care®; control eye). Lenses were worn for 2, 4 or 6 hours. Corneal staining was graded after lens removal. The Ocular Surface Cell Collection Apparatus was used to collect cells from the cornea and the contact lens.Results: In the test eye, maximum solution-induced corneal staining (SICS) was observed after 2 hours of lens wear (reducing significantly by 4 hours; p < 0.001). There were significantly more cells collected from the test eye after 4 hours of lens wear when compared to the control eye and the collection from the test eye after 2 hours (for both; n = 5; p < 0.001). The total cell yield at 4 hours was 813 ± 333 and 455 ± 218 for the test and control eyes, respectively (N = 5, triplicate, p = 0.003). A number of cells were observed to have taken up the fluorescein dye from the initial fluorescein instillation. Confocal microscopy of fluorescein-stained cells revealed that fluorescein was present throughout the cell cytoplasm and was retained in the cells for many hours after recovery from the corneal surface.Conclusion: This pilot study indicates that increased epithelial cell shedding was associated with a lens-solution combination which induces SICS. Our data provides insight into the transient nature of the SICS reaction and the nature of fluorescein staining observed in SICS.

Observation of solution-induced corneal staining with fluorescein, rose bengal and lissamine green

Ever since sodium fluorescein (‘fluorescein’ [FL]) was first used to investigate the ocular surface over a century ago, the term ‘staining’ has been taken to mean the presence of ocular surface fluorescence [1]. This term has not been necessarily taken to infer any particular mechanism of causation, and indeed, can be attributed to a variety of possible aetiologies [2]. In recent times, there has been considerable interest in a form of ocular surface fluorescence seen in association with the use of certain combinations of soft contact lenses and multipurpose solutions. The first clinical account of this phenomenon was reported by Jones et al. [3], which was followed by a more formal investigation by the same author in 2002 [4]. Jones et al described this appearance as a ‘classic solution-based toxicity reaction’. Subsequently, this appearance has come to be known as ‘solution-induced corneal staining’ or more recently by the acronym ‘SICS’ [5]. The term SICS is potentially problematic in that from a cell biology point of view, there is an inference that ‘staining’ means the entry of a dye into corneal epithelial cells. Morgan and Maldonado-Codina [2] noted there was no foundation of solid scientific literature underpinning our understanding of the true basic causative mechanisms of this phenomenon; since that time, further work has been published in this field [6] and [7] but questions still remain about the precise aetiology of this phenomenon...

Effect of Lens Care Systems on the Clinical Performance of a Contact Lens

To evaluate subjective responses, rates of solution-induced corneal staining (SICS), and corneal infiltrative events (CIEs) associated with a silicone hydrogel when worn under a daily disposable (DD) or daily wear (DW) modality. Data were obtained from seven prospective clinical trials, involving 283 subjects wearing Senofilcon A contact lenses (Johnson and Johnson Vision Care, Jacksonville, FL). Four groups wore the contact lens on a DW basis using multipurpose solutions (DW-MPS, n = 160), two groups using hydrogen peroxide (DW-H2O2, n = 83), and one group as a DD (n = 40). Participants were followed for 3 months using the same protocol. Subjective ratings were compared between DD and DW groups using a linear mixed model. Rates of SICS and CIE were calculated as the percent frequency of first events within the 3-month study. Association of SICS and CIE with subjective responses was analyzed using a linear mixed model. End-of-day comfort and dryness ratings were significantly better for DD (8.5 ± 1.7 and 8.6 ± 1.7, respectively) compared with DW-H2O2 (7.7 ± 1.8, p = 0.01; 7.6 ± 1.9, p = 0.006, respectively) and DW-MPS (7.7 ± 1.7, p = 0.004; 7.6 ± 2.0, p = 0.003, respectively). Compared with DD, a higher incidence of CIE and SICS was found for DW-MPS (0.0 vs. 3.9%, p = 0.021; 0.9 vs. 8.6%, p = 0.002, respectively). Comfort at insertion and end of day and end-of-day dryness scores were significantly lower for participants who experienced SICS (8.2 ± 1.6, 7.0 ± 1.9, and 7.0 ± 2.2) than those who did not (8.8 ± 1.2, p = 0.004; 7.9 ± 1.7, p = 0.002; and 7.9 ± 1.8, p = 0.003, respectively). Comfort at insertion scores were significantly lower for participants who experienced CIEs than those who did not (8.2 ± 1.5 vs. 8.8 ± 1.4, p = 0.032). Senofilcon A clinical response is modulated by the lens care products. All lens care products tested reduced subjective responses relative to DD modality, whereas MPS increased the incidence of CIEs and SICS. Senofilcon A performs best when used on a DD basis.

Tear cytokine response to multipurpose solutions for contact lenses.

PurposeAn increased risk of corneal infiltrative events has been noted with the use of certain contact lenses and multipurpose solutions (MPS). This study was designed to evaluate tear cytokine assay as a sensitive, objective, and quantitative measure of the ocular surface response to contact lens/MPS and to consider the assay’s clinical relevance in the context of other measures of ocular surface response.MethodsTwo MPS, ReNu® Fresh™ (RNF) and Opti-Free® RepleniSH (OFR), were used with daily wear silicone hydrogel contact lenses in a randomized, prospective crossover study involving 26 subjects. Clinical data collection (conjunctival hyperemia, ocular surface sensitivity, solution induced corneal staining (SICS) test score, and subjective responses) and tear cytokine assays were conducted masked. Responses were tracked as change from baseline throughout the experimental schedule.ResultsSimilar response patterns for several inflammatory cytokines were seen throughout both phases: subjects who received OFR in Phase I had mean tear concentrations that were generally higher than those of the RNF Phase I group. OFR Phase I subjects had significant (P < 0.01) increases over baseline at day 1 and/or following washout for 13 cytokines (cc chemokine ligands [CCL] 3, CCL5, CCL11, granulocyte-macrophage colony-stimulating factor [GM-CSF], interferon [INF]-γ, interleukin [IL]-2, IL-4, IL-5, IL-6, IL-13, IL-15, IL-17, tumor necrosis factor [TNF]-α). These changes were not observed in RNF Phase I subjects, even though SICS test scores increased. Phase I OFR subjects also had increased dryness, while RNF Phase I subjects had decreased bulbar hyperemia. No changes were detected with respect to limbal hyperemia or surface sensitivity thresholds.ConclusionThe tear cytokine assay can detect and differentiate contact lens/MPS induced increases in inflammatory cytokines. Changes in cytokine levels were consistent with measurement of hyperemia and dryness but not with SICS scores, thereby suggesting a proinflammatory response to OFR compared to RNF that is not related to SICS test score. Tear cytokine profiles may be useful for reconciling clinical relevance of test results and in revealing signaling involved in the development of corneal infiltrative events.

Associations between solution induced corneal staining, corneal infiltrative events, and Gram-negative bacteria case contamination

• Rates for CIE, SICS and GNB case contamination for four LCPs when used with balafilcon A (Bausch + Lomb, Rochester, USA) were obtained either from published data or calculated retrospectively. • The four LCPs were o LCP 1 containing sodium chlorite / H2O2: Sauflon Pharmaceuticals, Twickenham, UK. o LCP 2 containing alexidine dihydrochloride / polyquaternium (PQ)-1: Abbott Medical Optics, Inc., Santa Ana, USA. o LCP 3 containing PHMB / PQ-1: Bausch + Lomb, Rochester, USA. o LCP 4 containing PHMB: CIBA Vision, Duluth, USA. PURPOSE

The impact of saline rinsing on solution-induced corneal staining (SICS)

The impact of saline rinsing on solution-induced corneal staining (SICS)

Underlying mechanisms of sodium fluorescein staining using an in vitro model of solution-induced corneal staining (SICS)

Underlying mechanisms of sodium fluorescein staining using an in vitro model of solution-induced corneal staining (SICS)

Predisposing Factors for Solution-Induced Corneal Staining

To evaluate predisposing factors in subjects susceptible to solution-induced corneal staining (SICS). Four hundred forty-six existing soft contact lens wearers were randomly fitted with one of two study lenses (lotrafilcon B, CIBA Vision, or omafilcon A, CooperVision) and used a hydrogen peroxide care system (Clear Care, CIBAVision) for a 1-month period. Each subject was then challenged with the same lenses presoaked in a multipurpose solution (ReNu MultiPlus, Bausch & Lomb) and assessed after approximately 2 h to be categorized as either "stainers" or "non-stainers" based on whether they showed a classic SICS pattern (diffuse punctate corneal staining in three or more peripheral quadrants). Overall, 36% (155 of 425) of eligible subjects were classified as stainers and included a higher proportion of omafilcon wearers: 44% (91 of 205) vs. 29% (64 of 220). After using the peroxide system, the stainers were more likely to show poorer wetting (odds ratio [OR] = 1.76, p = 0.02) compared with the non-stainers. Lens wetting showed a significant negative correlation with film deposits (r = -0.63, p < 0.0001, n = 425). Furthermore, on slit lamp examination, the stainers were more likely to show higher levels of upper- and lower-palpebral hyperemia (OR = 2.18, p = 0.02; OR = 1.93, p = 0.04), tarsal roughness (OR = 1.71, p = 0.01), corneal staining (OR = 17.1, p < 0.0001), and conjunctival staining (OR = 1.94, p = 0.004). Although not exposed to preservatives, twice as many eyes in the stainers group had some level of corneal staining: 51% vs. 25%. There were no significant differences between the stainers and non-stainers with respect to age, sex, refraction, or keratometry (p > 0.05). This study highlighted some notable trends in patients susceptible to SICS. The findings point toward poor tear quality as a predisposing factor for SICS.

Corneal Staining and Cell Shedding during the Development of Solution-Induced Corneal Staining

This non-dispensing cross-over study was conducted to determine if lenses presoaked in Opti-Free RepleniSH (OFR) or ReNu MultiPlus (RMP) cause solution-induced corneal staining (SICS) and subsequent cell sloughing before the typical 2 h in vivo examination point. METHODS.: Study lenses (PureVision) were worn bilaterally by 13 participants for periods of 15, 30, 60, and 120 min using two different contralateral care regimen pairings. The lens worn on the test eye was soaked overnight in either OFR or RMP and the control eye in Clear Care (CC). After lens removal, corneal staining was rated on a scale of 0 (negligible) to 100 (severe) for four peripheral quadrants and the central region, and the differential global staining score was calculated by subtracting baseline staining scores. Following the staining assessment, corneal cells were collected from the ocular surface using a non-contact irrigation system to determine ocular cell shedding rates. Differential global staining score with OFR was greater than CC with the differences being statistically significant at 30 and 60 min (p < 0.01). Maximum staining with RMP was significantly greater than OFR and peaked after 60 and 120 min of lens wear (p < 0.01). On average, 710 ± 470 ocular cells were collected after lens wear, with similar shedding seen independent of solution or lens wear duration (p > 0.05). SICS occurred earlier but to a significantly lower degree when PureVision lenses were presoaked in OFR compared with RMP, while lenses presoaked in CC did not cause SICS. Ocular surface cell shedding after lens removal was not impacted by lens wear durations of ≤2 h.

Comparison of Ocular Comfort, Vision, and SICS During Silicone Hydrogel Contact Lens Daily Wear

The aim of this study was to investigate the relationship between solution-induced corneal staining (SICS) and silicone hydrogel contact lens comfort and vision. A retrospective analysis of a series of open-label studies were conducted with 24 groups of approximately 40 participants, each wearing 1 of 6 silicone hydrogel contact lenses with 1 of 4 lens care products bilaterally for 3 months of daily wear. The presence of SICS and subjective ocular ratings were collected at 2 weeks and at 1 and 3 months. A total of 1,051 participants were enrolled. The participants with SICS rated significantly less favorably than did the participants without SICS for comfort during the day (7.9±1.7 vs. 8.5±1.4, P=0.03), comfort at the end of the day (6.6±2.1 vs. 7.4±1.9, P=0.03), overall dryness (7.4±1.9 vs. 8.0±1.7, P=0.04), dryness at the end of the day (6.7±2.2 vs. 7.5±2.1, P=0.01), feelings of burning and stinging (8.5±2.0 vs. 8.9±1.8, P=0.02), and overall vision (8.2±1.6 vs. 8.7±1.3, P<0.001). The participants with SICS had lower subjective comfort and vision compared with those who did not experience SICS.

Underlying mechanisms of sodium fluorescent staining using an in vitro model of solution-induced corneal staining (SICS)

Underlying mechanisms of sodium fluorescent staining using an in vitro model of solution-induced corneal staining (SICS)

Does the observation of solution induced corneal staining signal the presence of corneal inflammation?

Purpose: To examine the differences in lipids deposits from worn silicone hydrogel materials (Balafilcon A and Lotrafilcon A) worn daily vs overnight. The deposits were analysed using Gas Chromatography Mass Spectrometry (GCMS). Method: Single lenses were extracted in chloroform: methanol (1:1) and transmethylated prior to analysis by GCMS. The lenses used were collected from a clinically controlled study (n=30) where lenses were worn daily or continuously for 30 days. Results: Lotrafilcon A lenses (16:0 average peak height 112 Kcounts) accumulated much less lipid than Balafilcon A (16:0 average peak height 1213 Kcounts). Results also showed a significant difference in lipid profile from lenses worn on a daily wear basis compared to those worn on a continuous wear basis and this was shown to be irrespective of lens material. The lenses that were worn daily for a month accumulated more unsaturated lipid such as C16:1 and C18:1. The lenses which had been worn continuously for the same period of time had little to no unsaturated fatty acids. Conclusions: Although atmospheric oxidation of lipids occurs during daily wear of contact lenses, oxidation of lens-immobilised lipids during successive periods of overnight wear is even more dramatic. The fact that lenses worn on an overnight basis for 30 days yielded predominately saturated lipids suggests that unsaturated lipids are oxidised during eye closure. This correlates with the known increase in inflammatory mediators in the overnight tear film and indicates a marked increase in free radical production leading to the degradation of unsaturated lipids.