Civamide Nasal Spray for the Treatment of Dry Eye

Civamide 鼻喷雾剂治疗干眼症

• 批准号: 10384841
• 负责人: Scott Phillips
• 金额: $ 16.03万
• 依托单位: ELORAC, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-01 至 2022-08-11
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10384841
• 关键词: Adult; Adverse effects; Adverse event; Affect; Agreement; Blurred vision; Chicago; Clinical Research; Communities; Controlled Study; Cornea; Development; Disease; Dose; Double-Blind Method; Drug Interactions; Drug Kinetics; Dry Eye Syndromes; Enrollment; Episodic Cluster Headaches; Esthesia; Eye; Fatigue; Feeling; Film; Foreign Bodies; Formulation; Funding; Gland; Goals; Grant; Headache Disorders; Lacrimation; Lead; Licensing; Measurable; Measures; Mediating; Medical; Migraine; Mucous Membrane; Nerve; Nerve Endings; Neurotransmitters; Nose; Ophthalmologist; Outcome; Pain; Participant; Patient Care; Patients; Persons; Pharmaceutical Preparations; Phase; Physiology; Pruritus; Randomized; Redness; Research; Safety; Serious Adverse Event; Severity of illness; Signs and Symptoms; Small Business Innovation Research Grant; Structure of mucous membrane of nose; Surface; Symptoms; Testing; Therapeutic; Therapeutic Effect; Tissues; Trigeminal nerve structure; Vision; absorption; associated symptom; clinical development; commercialization; effective therapy; experience; eye dryness; inclusion criteria; indexing; innovation; irritation; neurotransmitter transport; novel; novel strategies; novel therapeutics; open label; phase 2 study; phase 3 study; primary outcome; receptor; research and development; screening; side effect; treatment duration; treatment research

7. Project Summary/Abstract The project is a Phase II clinical study of Civamide Nasal Spray for the treatment of Dry Eye Disease, an irritating and potentially severely disabling ocular disease. If this study is successful in the treatment of Dry Eye Disease, further clinical development will proceed, i.e., Phase 3 studies to support the filing of a New Drug Application. Currently, all approved medications for treating Dry Eye Disease are directly instilled into the eye with the possibility of ocular side effects. Civamide Nasal Spray is unique in that it exerts its therapeutic effect locally in the nasal mucosa without systemic absorption being detected, as shown in a pharmacokinetic study.1 The availability of a safe and effective medication for Dry Eye Disease for these patients, i.e., Civamide Nasal Spray, will thus fill an unmet medical need. Civamide, a TRPV-1 receptor modulator,2,3 is a medication with a mechanism of action that affects nerves by modulating the synthesis, release, and transport of neurotransmitters. Dry Eye Disease is a disease of the surface of the eye, tear film, and related ocular tissues, including mucosal glands, which in part, are innervated by the trigeminal nerve.4,5,6 The trigeminal nerve also has superficial nerve endings in the nasal mucosa, which are the targets of Civamide Nasal Spray. By affecting these nerve endings, neurotransmitter physiology is affected throughout the entire nerve. Increased lacrimation as a result of this novel mechanism of action has been observed when Civamide Nasal Spray is applied to the nasal mucosa in both normal subjects and subjects with headache disorders mediated by the trigeminal nerve, e.g., migraine headache7 and cluster headache8. This proposed study is a 12 week, double-blind, vehicle-controlled study of adult subjects that have moderate to severe Dry Eye Disease for at least 6 months, and a Schirmer’s Test of ≤ 8 per 5 minutes in at least one eye at screening and baseline. The study is composed of a non-treatment Screening Period during which subjects will be required to meet study inclusion criteria, followed by a 12-week Double-Blind Treatment Period. Subjects will be randomized 1:1, approximately 20 subjects per group. The primary outcome variable will be the change in the Schirmer’s Test from Baseline to Day 84 of the Treatment Period. Adverse events will be recorded during the study.

7。项目摘要/摘要 该项目是一项II期临床研究，用于治疗干眼症的脑膜化鼻喷雾剂，这是一种 刺激性且可能严重致残眼疾病。如果这项研究成功地治疗了干眼症 疾病，进一步的临床发育将进行，即支持新药物的第三阶段研究 应用。目前，所有批准治疗干眼病的药物都直接灌输到眼睛中 具有眼副作用的可能性。 Civamide鼻喷雾是独一无二的，因为它发挥了治疗作用 如一项药代动力学研究所示，在没有检测到全身性滥用的鼻粘膜中的本地。1 这些患者的干眼症可用于干眼症的安全有效药物，即civamide鼻腔 喷雾，因此会满足未满足的医疗需求。 Civamide是TRPV-1受体调节剂，2,3是一种具有作用机理的药物，可影响神经 调节神经递质的合成，释放和运输。干眼症是一种疾病 眼睛表面，撕裂膜和相关的眼组织，包括粘膜腺，部分是支配的 通过三叉神经。4,5,6三叉神经在鼻粘膜中也具有浅表神经末端，该神经末端 是Civamide鼻喷雾剂的靶标。通过影响这些神经结尾，神经递质生理是 在整个神经中受到影响。由于这种新颖的作用机理的结果，富集增加了 当我们在正常受试者和 由三叉神经介导的头部疾病的受试者，例如偏头痛和簇 头痛8。 这项拟议的研究是一项为期12周的双盲，车辆控制的成人研究，具有现代化的受试者 至少有6个月的严重干眼症，而至少一只眼睛的Schirmer测试每5分钟≤8分钟 在筛选和基线。该研究由非治疗筛查期间组成，受试者在此期间 将要求满足研究纳入标准，然后进行12周的双盲治疗期。 受试者将被随机分为1：1，每组约20受试者。主要结果变量将是 从基线到治疗期第84天的Schirmer测试的变化。不利事件将是 在研究期间记录。