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/文摘