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2.
Clin Ophthalmol ; 7: 2037-42, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-24143071

RESUMEN

BACKGROUND: Concerns regarding the safety of cosmetically tinted contact lenses have been reported in the literature. The purpose of this paper is to evaluate the safety of cosmetically tinted contact lenses in a large number of patients across six clinical trials that varied from 1 week to 3 months in duration. METHODS: LENSES TESTED INCLUDED: Naturelle limbal ring daily disposable, Lacelle limbal ring daily disposable, Lacelle colored cosmetic daily disposable, Lacelle limbal ring planned replacement at 2 weeks, and Alamode traditional/annual colored cosmetic lens. The primary safety outcome was slit-lamp examination, including epithelial edema, epithelial microcysts, corneal staining, bulbar injection, limbal injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. High contrast logMAR visual acuity with lenses, and lens wearing time, movement, and centration, are also presented. RESULTS: A total of 871 subjects (1,742 eyes) and 23 clinical investigators participated in the six studies, with an average completion rate of 96.4% across all studies. The mean age of the patients was 26.8 ± 6.6 years, and 86.7% of participants were female. The total number of slit-lamp examinations across the six studies was 2,456 visits by eye (1,228 visits by patient). There were no slit-lamp signs > grade 2 for any finding, with the exception of corneal staining in one study. In this study, grade 3 corneal staining was noted in one eye (0.1%) at follow-up visit 1 and four (0.6%) of all eligible dispensed eyes at follow-up visit 2, with no eyes requiring medical treatment. No adverse events were reported during any of the trials. CONCLUSION: The cosmetically tinted lenses evaluated in this meta-analysis appear to be safe when properly prescribed by an eye care professional and used in a compliant manner.

3.
Clin Ther ; 34(6): 1259-1272.e1, 2012 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-22627057

RESUMEN

BACKGROUND: Seasonal allergic conjunctivitis (SAC) is caused by seasonal allergens and usually manifests as ocular itching and bulbar conjunctival injection (redness). Treatment options for SAC include corticosteroids and dual-acting antihistamine and mast-cell stabilizers. OBJECTIVE: Our objective was to compare the efficacy and tolerability of loteprednol etabonate (LE), a C-20 ester-based corticosteroid, with those of olopatadine, a dual-acting antihistamine mast-cell stabilizer, in Chinese patients. METHODS: This was a multicenter, randomized, investigator-masked, parallel group study. Patients with acute SAC experiencing grade 4 ocular itching and grade 2 or higher bulbar conjunctival injection received either LE suspension 0.2% QID at 4-hour intervals or olopatadine solution 0.1% BID at 6- to 8-hour intervals bilaterally for 15 days. Primary efficacy end points included the change from baseline (CFB) in ocular itching and bulbar conjunctival injection at day 15. The primary analysis tested the noninferiority of LE suspension 0.2% to olopatadine solution 0.1%. Tolerability outcomes included the incidence of adverse events (AEs), biomicroscopy findings, visual acuity, and intraocular pressure. RESULTS: A total of 300 patients were randomly assigned, and 293 were included in the per-protocol population (LE, n = 147; olopatadine, n = 146). Mean (SD) CFB at day 15 in the LE and olopatadine treatment groups, respectively, was -3.74 (0.47) and -3.28 (0.91) for ocular itching and -1.91 (0.52) and -1.71 (0.59) for bulbar conjunctival injection. The 95% CI for the differences in CFB in ocular itching (-0.59 to -0.27) and bulbar conjunctival injection (-0.27 to -0.08) was less than the prespecified noninferiority limit of 0.3. Treatment differences in CFB were significantly better with LE compared with olopatadine for both end points (P ≤ 0.0006). Ocular AEs were few and similar between treatment groups. There were no clinically significant biomicroscopy or visual acuity findings, and no patient experienced a clinically significant increase in intraocular pressure (≥10 mm Hg). CONCLUSION: Results of this investigator-masked study with Chinese patients suggest LE suspension 0.2% was noninferior to olopatadine solution 0.1% for the treatment of SAC. Both LE suspension 0.2% and olopatadine solution 0.1% were well tolerated. ClinicalTrials.gov identifier: NCT01435460.


Asunto(s)
Androstadienos/uso terapéutico , Antialérgicos/uso terapéutico , Conjuntivitis Alérgica/tratamiento farmacológico , Dibenzoxepinas/uso terapéutico , Administración Oftálmica , Adulto , Androstadienos/administración & dosificación , Androstadienos/efectos adversos , Antialérgicos/administración & dosificación , Antialérgicos/efectos adversos , China , Dibenzoxepinas/administración & dosificación , Dibenzoxepinas/efectos adversos , Método Doble Ciego , Esquema de Medicación , Humanos , Etabonato de Loteprednol , Clorhidrato de Olopatadina
5.
Biochim Biophys Acta ; 1638(1): 83-9, 2003 May 20.
Artículo en Inglés | MEDLINE | ID: mdl-12757938

RESUMEN

The protein product of hamster islet neogenesis-associated protein (INGAP) cDNA induces new pancreatic islet development. Manipulation of this process provides a new therapeutic strategy for the treatment of diabetes. As regulators of INGAP gene expression are unknown over 6 kb of hamster genomic INGAP has been cloned. Sequence analysis has identified a 3 kb 5-prime region with core promoter elements that is rich in transcription factor binding sites and six exons for the coding region. Analysis of promoter activity reveals stimulus-responsive DNA elements which have been identified though deletion analysis. Comparison of transcription factor binding sites in INGAP to the related gene RegIIIdelta exposes potential sites for differential gene regulation.


Asunto(s)
Antígenos de Neoplasias , Biomarcadores de Tumor , Lectinas Tipo C , Proteínas/genética , Animales , Secuencia de Bases , Sitios de Unión/genética , Línea Celular , Clonación Molecular , Cricetinae , ADN/genética , Diabetes Mellitus/terapia , Regulación de la Expresión Génica , Genes Reguladores , Genes Reporteros , Humanos , Intrones , Islotes Pancreáticos/crecimiento & desarrollo , Islotes Pancreáticos/metabolismo , Datos de Secuencia Molecular , Proteínas Asociadas a Pancreatitis , Regiones Promotoras Genéticas , Eliminación de Secuencia , Homología de Secuencia de Ácido Nucleico , Transfección
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