A Phase II/III, Randomized, Double-Masked, Vehicle-Controlled, Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sintetica SA
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Number of Participants in Phase 2 With Anesthesia Success
研究概览
简要总结
The study assess efficacy, safety and tolerability of Chloroprocaine 3% ophthalmic gel in healthy volunteers.
详细描述
The study is carried out in 2 parts. In part I, safety and tolerability is assessed in three groups (12 subjects per group) for single and multiple instillations (1 drop, 3 drops and 3+3 drops). In each group, 9 subjects is randomized to receive Chloroprocaine 3% Gel and 3 subjects receive vehicle as control in the right eye. After part I is completed, an internal independent board review safety endpoints of data collected from these first subjects and advise to go on with further enrollment.
If no safety concerns arise, in part II efficacy, safety and tolerability is assessed in 60 healthy subjects for the 3 drops dose regimen. 40 subjects receive Chloroprocaine 3% Gel and 20 receive vehicle (2:1 randomization) in the right eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent
- •Healthy male or female aged from 18 to 90 years
- •No clinically significant ocular or systemic disease
- •Ability to orally respond to pain
- •Ability to follow the visit schedule
排除标准
- •Ophthalmic exclusion criteria
- •Eye movement disorder (i.e. Nystagmus)
- •Dacryocystitis and all other pathologies of tears drainage system
- •History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis)
- •Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
- •History of ocular traumatism, infection or inflammation within the last 3 months
- •Best corrected visual acuity < 1/10
- •History of ophthalmic surgical complication (i.e. cystoid macular oedema)
- •Systemic/non ophthalmic exclusion criteria
- •General history:
- •8.1 Deafness 8.2 Excessive anxiety
- •Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplastic, haematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, uncontrolled hypertension: systolic blood pressure over 200 mm Hg, diastolic blood pressure over 100 mm Hg) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study
- •Allergic history: Known hypersensitivity to one of the components of the study medications or to test products
- •Specific non-inclusion criteria for women:
- •Pregnancy, lactation
- •Women without an effective method of contraception (i.e. oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) OR
- •Women not hysterectomised, not menopausal nor surgically sterilized
- •Exclusion criteria related to general conditions:
- •Inability of subject to understand the study procedures and thus inability to give informed consent
- •Non-compliant subject (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
- •Participation in another clinical study
- •Already included once in this study
- •Ward of court
- •Subject not covered by the Social Security
- •Exclusion criteria related to previous and concomitant medications (taken within 15 days prior screening visit)
- •Use of systemic opioids and opioid drugs
- •Topical ocular treatment with anaesthetic action
- •Use of systemic analgesic drugs (except paracetamol, which will be allowed after Visit 2)
研究组 & 干预措施
Chloroprocaine
Chloroprocaine 3% ocular gel
干预措施: Ocular gel (Drug)
Placebo
Vehicle for chloroprocaine 3% ocular gel
干预措施: Ocular gel (Drug)
结局指标
主要结局
Number of Participants in Phase 2 With Anesthesia Success
时间窗: Day 1
Estimate the proportion of subjects experiencing full anaesthesia of the ocular surface 5 minutes after administration of Chloroprocaine 3% ophthalmic gel (the intent was to collect and only report data for Participants who were in Phase 2)
次要结局
- Mean Arterial Pressure(up to 8 days)
- Duration of Anesthesia Only in Patients in Phase 2(Day 1)
- Number of Participants With Adverse Events(Up to 29 days)
- Number of Participants With Anomalies in Corneal Fluorescein Staining(up to 8 days)
- Ocular Pressure(Follow up (up to 8 days))
- Number of Participants With Anomalies in Slip Lamp Examination(up to 8 days)