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Topical Eyedrop Therapy for Keratoconus

圆锥角膜的局部滴眼液治疗

基本信息

批准号：
9409550
负责人：
Sarah Abdulla Molokhia
金额：
$ 22.48万
依托单位：
IVEENA DELIVERY SYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-30 至 2018-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9409550
关键词：
Amino Acids Animal Model Anterior Aqueous Humor Asthenopia Astigmatism Bilateral Biochemical Blood specimen Chemicals Clinical Trials Collagen Cone Contact Lenses Copper Copper Sulfate Cornea Data Descemet&apos s membrane Development Disease Disease Progression Dose Drug Kinetics Economic Burden Elements Evaluation Eye Eyedrops Eyeglasses Formulation Frequencies Glare High Pressure Liquid Chromatography High Prevalence Histologic Human Hydrophilic Contact Lenses Intervention Intraocular Lens Implantation Ions Keratoconus Keratoplasty Lasers Link Mechanics Methods Modeling Monocular Diplopia Morphology Operative Surgical Procedures Optical Coherence Tomography Oral Orphan Drugs Oryctolagus cuniculus Pathway interactions Patients Pharmacologic Substance Pharmacological Treatment Pharmacotherapy Phase Photophobia Photorefractive Keratectomy Placebo Control Procedures Progressive Myopia Protein-Lysine 6-Oxidase Research Retina Rupture Safety Shapes Small Business Innovation Research Grant Structure Technology Testing Therapeutic Thinness Time Tissues Toxic effect Toxicology Vision Visual Visual Acuity base corneal scar cost cost effective crosslink design dosage effective therapy evidence base health economics implantation in vivo life time cost man safety study success tomography

项目摘要

Project Summary Keratoconus (KCN) is a progressive disorder associated with structural changes in corneal collagen organization that leads to corneal thinning and ruptures in Bowman’s layer and/or Descemet’s membrane. As the disease progresses, it leads to irregular astigmatism, progressive myopia, and subsequently poor visual acuity. Treatment options are surprisingly limited with no oral or topical pharmaceutical therapy. Most mild KCN can be corrected with glasses or soft contact lenses but very often patients will need toric or hard contacts as the disease progresses. Ultimately, 1 in 5 patients will require surgery. Our technology is based on a co-factor for lysyl oxidase (LOX activity) and that low LOX activity in the cornea has been linked to the development of keratoconus both genetically and biochemically. We provide the evidence in preliminary results of a new topical eye drop effect on human keratoconus corneas in increasing both LOX activity and cornea stiffening. We also show the first morphological evidence of induced central corneal flattening in rabbits with optical coherence tomography (OCT). Based on the current evidence base, we outline new proactive pathways for keratoconus management and enabling a non-invasive and relatively cost effective treatment for keratoconus. We propose a research plan under three specific aims that will a) study the safety and tolerability of the eye drops in rabbits in vivo, b) study the effect of dosing frequency on rabbit corneal shape and biochemical crosslinking in vivo and c) to determine whether the eye drops induce biochemical crosslinking on human keratoconic corneas ex vivo.

项目总结