A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Ocular Safety of Articaine Sterile Topical Ophthalmic Solution
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects. It is designed to evaluate the ocular safety of a single topical ocular administration of AG-920 sterile topical ophthalmic solution compared to placebo..
详细描述
A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects performed in the US. It is designed to evaluate the ocular safety of one dose of AG-920 compared to placebo. I). In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 2:1 ratio to receive one dose of AG-920 or identical looking placebo into one (study) eye. A subset of subjects will undergo endothelial cell count (ECC) evaluations.
Each dose of AG-920 or placebo will consist of two drops in the study eye. After the completion of dosing, subjects will undergo a series of eye exams that will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The study is double masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent prior to any study-related procedures being performed.
- •Male or a non-pregnant, non-lactating female.
- •Healthy by clinical assessment, including ocular examination.
- •Have an Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) of 20/200 or better in both eyes.
- •Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.
- •Specular microscopy subset subjects only:
- •Have a central corneal endothelial cell density of ≥1500 cells/mm2 at baseline
排除标准
- •. Have participated in an investigational study within the past 30 days.
- •Have a contraindication to local anesthetics, Septocaine®, or any component of the IMP.
- •Have had ocular surgery or general surgery in either eye within the past 90 days.
- •Have had an intravitreal injection in either eye within 14 days of randomization.
- •Have ocular surface disease requiring punctal plugs.
- •Have evidence of any current ocular inflammation.
- •Current ocular allergy symptoms.
- •Have used topical, ocular medications in the 24 hours preceding dosing.
- •Systemic opioid, opiate analgesic or topical Non-steroidal Anti-Inflammatory Drug (NSAID) use within the past 30 days.
- •Previous participation in a clinical study of AG-
- •A current condition which could cause vision problems such as Pseudotumor Cerebri.
研究组 & 干预措施
AG-920
Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.
干预措施: AG-920 (Drug)
Placebo
Placebo Sterile Topical Ophthalmic Solution
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy.
TEAEs will be summarized by treatment group using frequency and percent for each system, organ, class (SOC) and preferred term within each SOC.
次要结局
- Mean Change From Baseline in Corneal Endothelial Cell Density After Treatment With AG-920(From Day 1 (treatment day) to 90 days following treatment)