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Clinical efficacy assessment in severe vernal keratoconjunctivitis: preliminary validation of a new penalties-adjusted corneal fluorescein staining score.

ABSTRACT: Introduction and objective: Vernal keratoconjunctivitis (VKC) is a rare allergic eye condition that occurs in children and is characterised by a combination of debilitating symptoms. Repeated use of topical corticosteroid rescue therapy is often necessary in severe forms. This study aims to assess the validity of a new composite endpoint: the penalties-adjusted corneal staining score (PACS-S) proposed as primary endpoint in VEKTIS trial evaluating the efficacy of a new corticosteroid-sparing treatment, VERKAZIA® (ciclosporin 1 mg/ml eye drops), in severe VKC patients. Methodology: This research comprised a systematic literature review to identify efficacy endpoints being proposed in clinical trials for pediatric patients with severe VKC, followed by a remote expert advisory board assessing the validity of the PACS-S. Results: While no agreed or validated endpoint for assessing efficacy in VKC was identified when VEKTIS trial started, the experts' board acknowledged a high face validity of PACS-S as a subjective integrated measure matching the current clinical practice. A fair external validity was considered with regards to VEKTIS trial secondary endpoints. Conclusion: PACS-S appears to be a reliable, valid and clinically meaningful primary endpoint that allows significant improvement over existing endpoints in severe VKC trials. Additional research is needed to validate this endpoint.

SUBMITTER: Leonardi A

PROVIDER: S-EPMC7170307 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:PurposeVernal keratoconjunctivitis (VKC) is a severe chronic allergic inflammation of the ocular surface with episodes of acute exacerbations, that primarily affects children and young adults. Although the etiology and pathogenesis of VKC remain unclear, studies have suggested that environmental factors may be involved. This study aims to investigate the association between exposure to meteorological and environmental factors and the incidence of VKC exacerbations.MethodsThis study was conducted in southern Israel, which is a semi-arid, hot, and dry climate with frequent dust storms. Patients diagnosed with VKC were recruited for the study. VKC exacerbations were identified as the need for medical intervention. Pollutants measured included nitrogen dioxide (NO2), ozone (O3), particulate matter (PM10 and PM2.5), sulfur dioxide (SO2), relative humidity (RH), temperature, and solar radiation (SR). To assess the association between VKC exacerbations and exposure to different pollutants, a case-crossover analysis was conducted. We also stratified the analysis by sex, age, ethnicity, immigration status, and social state score.ResultsOur results demonstrated that the pollutants NO2, O3, and PM10 were associated with VKC exacerbations with odds ratio (OR) = 2.17 (95% confidence interval [CI] =1.40 to 3.04), OR = 2.28 (95% CI = 1.30 to 3.39), and OR = 1.89 (95% CI = 1.06 to 2.74). Other pollutants PM2.5, temperature, and solar radiation were also independently associated with incidence of exacerbations with OR = 1.15 (95% CI = 0.87 to 1.50), OR = 1.75 (95% CI = 1.16 to 2.65), and OR = 1.37 (95% CI = 1.01 to 1.63) and had varying effects in different demographic strata.ConclusionsThe environmental parameters, NO2, O3, PM10, PM2.5, temperature, and solar radiation were found to be significantly associated with VKC exacerbations, with NO2, O3, and PM10 showing the strongest associations. Our findings suggest that environmental factors should be considered when developing strategies to prevent and manage VKC exacerbations.

Project description:IntroductionVernal keratoconjunctivitis is a chronic bilateral severe form of allergic conjunctivitis which affects normal activities in school/work. It is a severe form of allergies in warm and dry tropical and sub-tropical countries. Its prevalence in Ethiopia ranges from 5.2% to7.3%. Most studies are institution based and do not address specific factors associated with vernal keratoconjunctivitis. There is no a study that shows the magnitude of vernal keratoconjunctivitis in the study area.ObjectiveTo assess the prevalence of vernal keratoconjunctivitis and its associated factors among children in Gambella town, Southwest Ethiopia, 2018.Methods and materialsA community based cross-sectional study was conducted from April 25 to May 12, 2018, in Gambella town. A total of 578 study participants were selected using a systematic random sampling technique. A pre-tested semi-structured questionnaire, torch, and magnifying loop were used to collect data. The data was entered into epidemiological information 7.1 and exported to statistical package for social science for analysis. Binary logistic regression analysis model was fitted to identify factors associated with vernal keratoconjunctivitis. Odds ratio with respected 95% CI was used to identify the direction and strength of association.ResultsA total of 574 children participated in this study representing a response rate of 99.30%. The mean age of the participants was 9.74±4.0 years. The prevalence of vernal keratoconjunctivitis was 11.10% (95% CI: 8.70, 13.90). Male sex (adjusted odds ratio = 4.12(95% CI: 1.42, 11.91)), close animal contact (adjusted odds ratio = 3.45(95% CI: 1.14, 10.41)), dust exposure (adjusted odds ratio = 3.38(95% CI: 1.31, 10.04)), and personal systemic allergy history (adjusted odds ratio = 4.82(1.40, 16.72) were independently associated with vernal keratoconjunctivitis.ConclusionThe prevalence of VKC was high among children in Gambella town. Sex being male, close animal contact, personal systemic allergy history, and dust exposure were positively associated with vernal keratoconjunctivitis independently.

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Clinical efficacy assessment in severe vernal keratoconjunctivitis: preliminary validation of a new penalties-adjusted corneal fluorescein staining score.

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