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. 项目总结/摘要 该项目是Civamide鼻喷雾剂治疗干眼症的II期临床研究。 刺激性且可能严重致残的眼部疾病。如果这项研究成功治疗干眼症 疾病，将进行进一步的临床开发，即支持新药申请的三期研究 应用。目前，所有批准治疗干眼病的药物都是直接滴入眼睛 可能会产生眼部副作用。 Civamide鼻喷雾剂的独特之处在于它发挥了治疗作用 如药代动力学研究所示，局部存在于鼻粘膜中，未检测到全身吸收。1 为这些患者提供安全有效的干眼病药物，即 Civamide Nasal 喷雾剂将因此填补未满足的医疗需求。 Civamide 是一种 TRPV-1 受体调节剂，2,3 是一种具有通过以下方式影响神经的作用机制的药物： 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、泪膜和相关眼组织，包括部分受神经支配的粘膜腺 由三叉神经支配。4,5,6 三叉神经在鼻粘膜中也有浅表神经末梢， 是 Civamide 鼻喷雾剂的目标。通过影响这些神经末梢，神经递质生理学 影响整个神经。这种新颖的作用机制导致流泪增加 当将 Civamide 鼻喷雾剂施用于正常受试者和受试者的鼻粘膜时，观察到 患有由三叉神经介导的头痛疾病的受试者，例如偏头痛7和丛集性头痛 头痛 8. 这项拟议的研究是一项为期 12 周的双盲、媒介对照研究，对象为患有中度糖尿病的成人受试者。 患有严重干眼病至少 6 个月，并且至少一只眼睛的 Schirmer 测试每 5 分钟 ≤ 8 在筛选和基线时。该研究由一个非治疗筛选期组成，在此期间受试者 需要满足研究纳入标准，然后是 12 周的双盲治疗期。 受试者将以 1:1 的比例随机分配，每组大约 20 名受试者。主要结果变量将是 Schirmer 测试从基线到治疗期第 84 天的变化。不良事件将会 研究期间记录。