A Prospective, Observer-masked, Randomized Clinical Trial to Investigate and Compare the Clinical Efficacy of Chloroprocaine 3% Gel and Tetracaine 0.5% Eye Drop as Topical Anestheticsin Phacoemulsification.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sintetica SA
- 入组人数
- 338
- 试验地点
- 27
- 主要终点
- Number of Participants in Each Treatment Group With a Successful Surface Anesthesia
研究概览
简要总结
Randomized clinical trial, multicenter, two-armed, to investigate and compare the clinical efficacy of chloroprocaine 3% gel and tetracaine 0.5% eye drop as topical anestheticsin phacoemulsification. This prospective, observer masked, randomised, controlled, equivalence phase 3 study will be conducted in approximately 4 European Countries. Sintetica intends to perform a phase 3 study on patients undergoing cataract surgery to assess the safety and efficacy of topical anaesthesia using chloroprocaine gel.
详细描述
Prospective,randomized, multi-center, active-controlled, masked-observer, parallel-group, competitive equivalence study. The study has been designed to assess the equivalence of chloroprocaine 3% gel (Test) with respect to tetracaine 0.5% solution (Reference) in surface anesthesia. Patients in both groups will receive three drops of study products before surgery. The study will include a Selection visit (Day -90/Day -1), an Inclusion visit (Day 1/surgery day), a Follow-up visit (Day 2, phone visit), a Final visit (Day 8), and a Follow-up phone call - Optional (Day 28, phone visit).
Selection visit (Visit 1, Day -90/Day -1):
Patients scheduled to undergo cataract surgery in a single eye will be informed about the aims, procedures and possible risks of the study and will be asked to sign the informed consent form for the inclusion in the trial.
Inclusion visit/Surgery (Visit 2, Day 1):
Before the anesthesia, patients will be questioned about previous and concomitant ocular and non-ocular treatments. Inclusion /exclusion criteria and patient status will be verified. Patients will be randomized to either chloroprocaine 3% gel (Test) or tetracaine 0.5% eye drop (Reference) treatment group.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent
- •Male or female aged≥ 18 years
- •Senile or pre-senile cataract
- •Scheduled to undergo cataract surgery in a single eyeat a time (clear corneal self-sealing incisions - phacoemulsification - foldable intra-ocular lens surgery with injector)
排除标准
- •Combined surgery
- •Previous intraocular surgery
- •Previous corneal refractive surgeries less than 6 months before screening
- •Non Senile or non pre-senilecataract (e.g.: traumatic, pathological or congenital cataract)
- •Pupillary abnormalities (irregular, etc.)
- •Iris synechiae
- •Eye movement disorder (nystagmus, etc.)
- •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
- •Pseudo-exfoliation, exfoliative syndrome
- •Prior intravitreal injections within 7 days of the surgery
- •IOP over 25mmHg under treatment
- •Best corrected visual acuity < 1/10
- •Patient already included in the study for phakoexeresis
- •History of ophthalmic surgical complication (cystoid macular oedema, etc.)
- •Diabetes mellitus
- •Pakinsondisease
- •Excessive anxiety
- •Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, hematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, bradycardia, atrial fibrillation,uncontrolled hypertension: systolic blood pressure over 140 mm Hg, diastolic blood pressure over 90 mmHg) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study.
- •Known hypersensitivity to sulfonamides products or any of the components of the study medications or to test products Specific exclusion criteria for women
- •Pregnancy (positive pregnancy test), lactation
- •Women of childbearing potential without an acceptable effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) until end of the study participation OR
- •Women not hysterectomized, not menopaused nor surgically sterilized. Exclusion criteria related to general conditions
- •Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent
- •Non-compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
- •Participation in anotherclinicalstudy
- •Already included once in this study
- •Ward of court
- •Patient not covered by the Social Security
研究组 & 干预措施
Chloroprocaine 3%
All the eligible patients will be administrated by Chloroprocaine 3 % according to the randomization criteria.
干预措施: Chloroprocaine 3% (Drug)
Tetracaine 0.5%
All the eligible patients will be administrated by Tetracaine 0.5% according to the randomization criteria.
干预措施: Tetracaine 0.5% (Drug)
结局指标
主要结局
Number of Participants in Each Treatment Group With a Successful Surface Anesthesia
时间窗: Before Intra Ocular Lens (IOL) implantation surgery.
Τhe primary endpoint is the number of partecipants in each treatment group with a successful surface anesthesia, without any supplementation at the time point T4 (1 minute after the 3rd drop installation)
次要结局
- Corneal Thickness(Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days)
- Number of Participants With Abnormalities of the Retina, Macula, or Optic Nerve by Fundoscopy(Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days)
- Changes in Ocular Symptoms(Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days)
- Objective Ocular Signs(Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days)
- Best Far Corrected Visual Acuity(Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days)
- Surgeon Satisfaction(day 1 - visit2 (Inclusion visit/Surgery))
- Fluoresceine(Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days)
- Endothelial Cell Counts(Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days)
- Patient Global Satisfaction(day 1 - visit2 (Inclusion visit/Surgery) after the treatment)
- Intra-ocular Pressure(Visit 1 (Day -90/Day -1) and Visit 4 (Day 8 ± 1 day), up to approximately 102 days)