A Prospective, Observer-blind, Randomized Clinical Trial to Investigate and Compare the Clinical Efficacy of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia for Clinical Practice in Pediatric Population
概览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sintetica SA
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Conjunctiva Anesthesia With Chloroprocaine 3% Eye Gel as Compared With Oxybuprocaine Chlorhydrate 0.4% Eye Drops
概览
简要总结
The goal of this clinical trial is to assess the efficacy and safety of Chloroprocaine 3% eye gel compared to Oxybuprocaine 0,4% eye drops when used for inducing ocular surface anesthesia in pediatric patients.
74 Participants (male and female, aged 0-17 yrs) will be 1:1 randomized for receiving either the test drug (Chloroprocaine) or the reference drug (Oxybuprocaine) before undergoing to ocular exam who needs ocular surface anesthesia.
The successful surface anesthesia will be evaluated 5 minutes after receiving 2 drops (1 minute apart) of either test or reference drug by an eye spear sponge
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be enrolled in this study, patients must fulfil all these inclusion criteria:
- •Age ≥ one day of life (newborn, infant, child) and 17 years included (not anticipated to turn 18 during the study).
- •Female subjects currently either of:
- •Non-childbearing potential (i.e., premenarchal or physiologically incapable of becoming pregnant, including any female who is surgically sterilized via documented hysterectomy or bilateral tubal ligation), or
- •Childbearing potential (i.e., postmenarchal girls): the subject is eligible to enter and participate in this study if she is not lactating, has a negative pregnancy test and agrees to abstain from intercourses or uses a valid contraceptive method until study completion.
- •Signed written informed consent by both parents or legal representative(s) (unless only one has legal authority). Written informed assent for adolescents aged 12-17 years included and, whenever possible, informed assent for children aged 6 to 11 years included. Ability of the subjects and their parents/legal representative(s) to understand and comply with the protocol requirements, study-specified visit schedule and procedures.
- •Scheduled to undergo a routine clinical procedure which needs local ocular surface anesthesia, including but not limited to applanation tonometry, gonioscopy, Ultrasound Biomicroscopy (UBM), ocular ultrasonography, retinal peripheral examination with blepharostat and scleral indentation.
排除标准
- •Patients fulfilling at the inclusion visit one or more of the following exclusion criteria will not be enrolled in the study:
- •Ophthalmic exclusion criteria
- •Previous ocular surgery less than 6 months before screening
- •Eye movement disorder (nystagmus)
- •History of herpetic keratitis
- •Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration, corneal damage and superficial punctuate keratitis)
- •History of ocular traumatism, infection or inflammation within the last 3 months Systemic/non ophthalmic exclusion criteria
- •General history:
- •Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasia, hematological diseases, severe psychiatric illness, cardiac rhythm disorders and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study
- •Allergic history:
研究组 & 干预措施
Chloroprocaine 3% gel
The assigned investigational product (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
干预措施: Chloroprocaine 3% eye gel (Drug)
Oxybuprocaine 0,4% solution
The assigned active comparator (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
干预措施: Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops (Drug)
结局指标
主要结局
Conjunctiva Anesthesia With Chloroprocaine 3% Eye Gel as Compared With Oxybuprocaine Chlorhydrate 0.4% Eye Drops
时间窗: day 1
Efficacy outcome: assess of patients in each treatment group with a successful conjunctiva anesthesia in the right eye, 5 minutes after study product administration, i.e. right before the ocular examination, to be assessed by eye spear sponge.
次要结局
- Number of Participants With Adverse Events(from day 1 until study end (day 8 or day 15))
- Assessing the Product Global Tolerance Graded(day 1, post dose)