2023-504477-21-00撤回3 期
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.
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Primary endpoint will be to assess the proportion 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.
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of Chloroprocaine 3% ophthalmic gel as compared to Oxybuprocaine chlorhydrate 0.4% eye drops anesthesia for clinical practice in pediatric population
研究设计
- 分配方式
- Randomized
- 主要目的
- A Prospective, Observer-blind, Randomized Clinical Trial To Investigate And Compare The Clinical...
- 盲法
- Single (Investigator, Subject)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 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 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:
- •Known hypersensitivity to one of the components of the investigational products
- •Exclusion criteria related to general conditions
- •Non-compliant patient and/or parent(s)/legal representative(s) (e.g., not willing to attend the follow-up visits, way of life interfering with compliance)
- •Participation in another clinical study in the last three months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study
- •Already included once in this study
- •Exclusion criteria related to previous and concomitant medications / nonproduct therapies
- •Patient using any of the following previous and concomitant medication / treatment (according to the described periods) will not be included in the study: BEFORE INCLUSION (30,15,7 days) and Inclusion (day 1): Any change in concomitant anti-depressant medication, Any topical ocular treatment. BEFORE INCLUSION (15,7 days) and Inclusion (day 1): Systemic opioids and morphine drugs. BEFORE INCLUSION (7 days) and Inclusion (day 1): Any change in other systemic medication already ongoing before inclusion visit. Inclusion (day 1): Others systemic antalgics drugs*. *Paracetamol after primary endpoint assessment and oral, implantable, transdermal, or injectable contraceptives for child-bearing potential girls during the entire study will be allowed.
结局指标
主要结局
Primary endpoint will be to assess the proportion 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.
Primary endpoint will be to assess the proportion 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
- Safety endpoints: - Objective ocular signs (palpebral edema, chemosis, conjunctival hyperemia, conjunctival discharge, follico-papillary conjunctivitis, corneal staining punctuations, anterior chamber cells, flare) and other objective ocular signs, assessed by slit lamp examination (SLE) or binocular indirect ophthalmoscopy (BIO), will be graded according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe.
- Safety endpoint: Adverse events occurrence throughout the study
- Safety endpoints: Product global tolerance will be graded by the Investigator by answering the following question “How do you consider the study product global tolerance” using the following scale: 0=very unsatisfactory, 1=unsatisfactory, 2= satisfactory, 3=very satisfactory.
研究者
Sergio Cantoreggi
Scientific
Sintetica S.A.
研究点 (3)
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