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Purpose: To analyze changes in tear levels of inflammatory mediators in symptomatic contact lens (CL) wearers after refitting with daily disposable CLs and to identify potential biomarkers of success in CL discomfort (CLD) management. Methods: Symptomatic CL wearers (CLDEQ-8 ≥ 12) were refitted (V1) with daily disposable CLs (Delefilcon A). After one month (V2), participants were classified into the post-fitting non-symptomatic (CLDEQ <12) and symptomatic (CLDEQ ≥12) groups. At each visit, the participants were clinically evaluated, tears were collected, and 20 inflammatory mediators and substance P (SP) were measured using multiplex immunobead analysis and ELISA, respectively. The detection rates and concentrations were compared between visits and groups, and logistic regression models were performed. Results: Forty-three subjects (32 women/11 men; mean age: 23.2 ± 4.9 years) were enrolled. The IL-1β and IL-9 detection rates were higher at V2 (p ≤ 0.044). The detection rates of IL-1β, IL-9, MIP-1α/CCL3, and MMP-9 at V1 (p ≤ 0.045) and IL-17A at V2 (p ≤ 0.014) were higher in the post-fitting symptomatic group. The tear IL-9 concentration was increased at V2 (p = 0.018). The tear concentrations of fractalkine/CX3CL1, IL-2, IL-6, IL-10, MCP-3/CCL7, MIP-1β, NGF, RANTES/CCL5, and TNF-α were higher in the post-fitting symptomatic group (p ≤ 0.044). Additionally, levels of fractalkine/CX3CL1, IL-2, IL-6, IL-10, RANTES/CCL5, and TNF-α at V1 were significantly associated with the post-fitting grouping (p ≤ 0.044). Conclusions: Low tear concentrations of specific inflammatory mediators may be used as a predictive biomarker of success for refitting symptomatic CL wearers with daily disposable CLs. However, complementary treatments might be required for symptomatic CL wearers with higher levels of these inflammatory molecules. [ABSTRACT FROM AUTHOR]

Questionnaires can provide unique information regarding the status of a condition from the perspective of the patient. Contact lens (CL) discomfort (CLD) is a condition subjectively reported by CL users; thus, updated and reliable questionnaires are needed. The objective of this study was to design a new questionnaire for identifying CLD, based on the currently established CLD definition considered in the Tear Film and Ocular Surface CLD Workshop. A survey to characterise CL wearers was created and administered. Some items of the survey were selected by a focus group and analysed using a Rasch model to develop a questionnaire to identify CLD. Unidimensionality was checked applying principal components analysis. To build a plausible CLD classification (symptomatic vs asymptomatic), an unsupervised cluster analysis was used. Gower's general similarity coefficient, the partitioning around medoids algorithm, and the silhouette width were calculated. The reliability of the questionnaire was assessed using the intraclass correlation coefficient and Cohen's kappa coefficient. A study was performed to compare this questionnaire with the Contact Lens Dry Eye Questionnaire (CLDEQ)-8. The 31-item survey was completed by 1104 volunteers, and the posterior analysis resulted in a 9-item questionnaire, the Contact Lens Discomfort Index (CLDI). It showed a good fit with the model (mean square infit and outfit values range was 0.76–1.10), and good unidimensionality (eigenvalues ≤ 1.3). The CLDI score range was 0–18 and the cut-off score for identifying CLD was 8. The intraclass correlation coefficient was 0.88 (95% confidence interval, 0.75–0.94), and kappa was 0.67 (95% confidence interval, 0.41–0.93). Comparison of the CLDI with the CLDEQ-8 in a sample of 58 CL wearers showed that 70.7% were classified equally by both questionnaires. The CLDI is a well-structured instrument, with acceptable psychometric properties, making it a valid and reliable tool to measure CL-related symptoms. [ABSTRACT FROM AUTHOR]

Purpose: To identify alterations in neuropathic and inflammatory pain gene expression associated with contact lens (CL) wear and CL discomfort (CLD).Methods: Eight non-wearers, eight asymptomatic CL wearers (CLWs) and eight symptomatic CLWs were included. Conjunctival cells were collected by impression cytology and the mRNA expression levels of 85 genes were analyzed. Differentially expressed genes between non-wearers and CLWs and between asymptomatic and symptomatic CLWs were analyzed. An enrichment analysis was also performed.Results: Twelve genes were upregulated (including IL10, PDYN and PENK) and 28 downregulated (CCL2, IL1A, IL1B, IL2 and NGF) in CLWs (p ≤ 0.050). Eleven genes were upregulated (CCL2, IL1A, IL1B, IL2 and NGF) and nine downregulated (PDYN and PENK) in symptomatic CLWs (p ≤ 0.035). Enriched overrepresented terms were related to pain, neuronal transmission and inflammation.Conclusion: Contact lens wear might produce a desensitization-like mechanism responsible for comfortable CL wear. A malfunction of this mechanism might contribute to CLD. [ABSTRACT FROM AUTHOR]

Purpose: To analyze the effects of contact lens (CL) wear, time of the day, and CL discomfort (CLD) on clinical signs, tear inflammatory mediators and substance P.Methods: Thirty symptomatic and 30 asymptomatic CL wearers attended two visits (morning and afternoon) on two days (non-CL and CL wearing days). Comfort, meniscus area, noninvasive breakup time (NIBUT), tear collection, hyperemia, lid parallel conjunctival folds, fluorescein staining, and sensitivity were performed. The tear levels of 23 inflammatory mediators and substance P were measured.Results: Comfort, meniscus area, NIBUT, and MMP-9 were lower while conjunctival staining and EGF higher (p ≤ 0.015) on the CL wearing day. Comfort, IL-8/CXCL8, and VEGF were lower while EGF, IP-10/CXCL10, and MCP-1/CCL2 higher (p ≤ 0.047) in the afternoon. Comfort was lower and substance P higher (p ≤ 0.006) in symptomatic wearers.Conclusion: Substance P may be implicated in CLD etiology; its role and potential application as a biomarker should be further studied. [ABSTRACT FROM AUTHOR]

Purpose: To study whether some ocular surface alterations could be associated with contact lens (CL) wearers suffering from CL discomfort (CLD) detected using the Contact Lens Dry Eye Questionnaire (CLDEQ)-8.Methods: Forty-one soft CL wearers further classified into symptomatic CL wearers (SCLW) and asymptomatic CL wearers (ACLW) by the CLDEQ-8, and 20 non CL wearers (NCLW) were included. Tear osmolarity, slit-lamp biomicroscopy findings, tear film break-up time, corneal and conjunctival staining, and Schirmer test were performed 24 h after CL removal. Data were compared among groups using the analysis of variance and the Student t-test or the Kruskal-Wallis H and the Mann-Whitney U tests, applying the Bonferroni correction. Correlations between the CLDEQ-8 and the clinical signs were performed using the Spearman correlation coefficient.Results: Twenty-four SCLW, 17 ACLW and 20 NCLW were recruited. There were significant differences among groups for tear osmolarity (p < 0.001), limbal hyperaemia (p = 0.014), and tarsal hyperaemia (p = 0.031). Pairwise comparisons revealed that SCLW and ACLW had higher tear osmolarity (p < 0.003, both comparisons) and limbal hyperaemia (p = 0.027 and p = 0.048, respectively) than NCLW. Moreover, SCLW had higher tarsal hyperaemia (p = 0.030) than NCLW. No significant correlations were found (p > 0.05).Conclusion: The CLDEQ-8 was ineffective to detect clinical alterations between SCLW and ACLW; therefore, the use of questionnaires alone remains being the best approach to detect CLD. The role of the tarsal conjunctiva in the development of CLD should be analyzed in future studies. [ABSTRACT FROM AUTHOR]

This study aimed to assess the subjective and objective differences among the steps of the contact lens discomfort (CLD) progression classification established by the Tear Film & Ocular Surface Society (TFOS) using questionnaires and clinical signs, and to propose a simplified classification. Contact lens (CL) wearers were evaluated in a single visit. The Contact Lens Dry Eye Questionnaire (CLDEQ)-8, the Contact Lens Discomfort Index, and Visual Analog Scales for discomfort and dryness were administered. The non-invasive break-up time, the tear film lipid layer thickness, conjunctival hyperaemia and papillae, lid-parallel conjunctival folds, the fluorescein tear film break-up time, corneal and conjunctival staining, lid wiper epitheliopathy, and the Schirmer test were assessed. Sign and symptom scores were compared among TFOS CLD progression steps using analysis of variance or the Kruskal–Wallis H test. Steps 1 and 2 (reduced comfort), and steps 3 and 4 (reduced wearing time) of the TFOS classification were combined to obtain a simplified classification, and the same comparison was performed. A p-value ≤ 0.05 was considered statistically significant. One hundred-fifty CL wearers (97 women and 53 men) aged 34.4 ± 12.6 years were included. In the TFOS classification, there were significant differences between step 0 (no CLD) and the rest of the severity steps for the scores obtained in all questionnaires (p ≤ 0.015). All steps were differentiated (p ≤ 0.032) based on the simplified classification for all questionnaires, except steps 1 and 2 for the CLDEQ-8 and dryness VAS (p = 0.089 and p = 0.051, respectively). There were no differences (all p ≥ 0.06) between the sign scores among the steps of either classification. CLD management is encouraged from its first appearance. Simplifying the phases of CLD severity may allow a more accurate classification and a better awareness of the problem by clinicians and CL wearers by using more straightforward simple messages. [ABSTRACT FROM AUTHOR]

Purpose: To study whether contact lens (CL) discomfort and some properties of soft CL materials are associated with alterations in the nerve fibers morphology and density of dendritic cells of the corneal sub-basal nerve plexus. Materials and Methods: Forty soft CL wearers and 20 non-CL wearers were included. The Contact Lens Dry Eye Questionnaire-short form was administered to divide CL wearers based on their symptoms (20 symptomatic and 20 asymptomatic CL wearers were included). The CL material properties considered were the CL material type (16 hydrogel and 24 silicone hydrogel CL wearers were included), water content, oxygen transmissibility, and modulus of elasticity. Confocal microscopy was performed, and the number and density of corneal nerves, density of nerve branches, grade of nerve tortuosity, and density of dendritic cells were analyzed. The effects of CL discomfort and CL material properties on the confocal microscopy parameters were analyzed. Results: No significant differences were found among symptomatic and asymptomatic CL wearers and non-CL wearers in any of the confocal microscopy parameters evaluated. The density of dendritic cells was higher in the hydrogel CL wearers compared to the silicone hydrogel CL wearers and non-CL wearers (p = 0.002). The density of dendritic cells tended to be higher as the oxygen transmissibility decreased (β = −0.40, p = 0.07). Conclusions: CL discomfort appears not to be associated with alterations in the corneal sub-basal nerve plexus. Hydrogel CL wear might be involved in the recruitment of dendritic cells into the cornea, being a possible origin its lower oxygen permeability compared to silicone hydrogel materials. Future studies are required to confirm these results. [ABSTRACT FROM AUTHOR]

Purpose To assess the influence of different indoor environments simulated in an environmental chamber on soft contact lens ( CL) wearers. Methods Fifty-four CL wearers were grouped based on their symptoms while wearing their CLs. Subjects were fitted with two different CL types, conventional hydrogel (Omafilcon A) and silicone hydrogel (comfilcon A), and exposed to two controlled indoor environmental conditions, standard [50% relative humidity ( RH), 23°C, 930 mb of atmospheric pressure] and adverse (in-flight air cabin environment: 5% RH, localised air flow, 23°C, 750 mb atmospheric pressure), for 90 min in an environmental chamber, making a total of four visits. Symptoms, tear osmolarity, pre-lens tear breakup time ( PLBUT), phenol red thread test, visual acuity, bulbar and limbal hyperaemia, corneal and limbal staining, and CL dehydration were assessed using repeated measures analysis of variance. A linear mixed model was used to analyse the effect of environment, CL type, discomfort-based grouping, and time on blink rate. Results Environment was found to significantly ( p ≤ 0.018) affect limbal and bulbar hyperaemia, PLBUT, tear osmolarity, and CL dehydration. Likewise, CL type significantly ( p ≤ 0.04) affected nasal and total corneal staining, limbal conjunctival staining, CL dehydration, comfort, and blurred vision. The environment, CL type, and time had significant effects ( p ≤ 0.0001) on the blink rate. Conclusions Ocular surface integrity and blink rate in CL wearers depend on the environment CL users are exposed to, as well as on the soft CL type that they are wearing. Tight control of environmental conditions can contribute to a better understanding of CL-related discomfort. [ABSTRACT FROM AUTHOR]

Purpose: To examine the relationship between contact lens (CL) discomfort and meibomian gland (MG) morphology assessed by a semi-objective software in subjects without an alteration of MG function (meibum quality and expressibility).Methods: Nineteen symptomatic (CLDEQ-8 ≥ 12) CL wearers, 19 asymptomatic (CLDEQ-8 < 12) wearers, and 22 non-wearers were recruited. Upper and lower eyelid meibography images were taken and the following parameters were analysed using a semi-objective software in the central 2/3 of each eyelid: number of MG, number of partial MG, percentage of MG loss and percentage of tortuosity. One-way ANOVA or Kruskal-Wallis H test were used for comparisons among groups. The relationships between CLDEQ-8 and MG morphology parameters were analysed using the Spearman correlation coefficient and multivariable linear regression models.Results: No significant differences were found among groups in the MG morphology of the upper or lower eyelids. In all CL wearers, a significant correlation with CLDEQ-8 was found in the upper eyelid for the number of MG (rho = 0.47, p = 0.003). In symptomatic wearers, significant correlations with CLDEQ-8 were found in the lower eyelid for the number of partial MG (rho = 0.49, p = 0.03) and the percentage of partial MG (rho = 0.61, p = 0.005). In all CL wearers, multivariable models were fitted to explain CLDEQ-8 score including the number of MG, the number of partial MG and the percentage of MG loss from the lower eyelid (R2 = 0.19; p = 0.007), and the number of MG from the upper eyelid (R2 = 0.19; p = 0.001). In symptomatic wearers, a model was fitted including the percentage of MG loss from the lower eyelid (R2 = 0.30; p = 0.016).Conclusions: Alterations of MG morphology, without clinically apparent alteration of MG function, can be involved in causing CL discomfort and influence the degree of symptoms. The differences in findings between eyelids indicate the need to monitor both eyelids, especially the lower one, in CL wearers. [ABSTRACT FROM AUTHOR]