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.

CHL.3/01-2019/M

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.

2020-09-09

2021-03-01

2021-03-09

Completed

Early phase I

338

Inclusion Criteria: 1. Signed and dated informed consent 2. Male or female aged≥ 18 years 3. Senile or pre-senile cataract 4. Scheduled to undergo cataract surgery in a single eyeat a time (clear corneal self-sealing incisions - phacoemulsification - foldable intra-ocular lens surgery with injector) Exclusion Criteria: 1. Combined surgery 2. Previous intraocular surgery 3. Previous corneal refractive surgeries less than 6 months before screening 4. Non Senile or non pre-senilecataract (e.g.: traumatic, pathological or congenital cataract) 5. Pupillary abnormalities (irregular, etc.) 6. Iris synechiae 7. Eye movement disorder (nystagmus, etc.) 8. Dacryocystitis and all other pathologies of tears drainage system 9. History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis) 10. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis) 11. History of ocular traumatism, infection or inflammation within the last 3 months 12. Pseudo-exfoliation, exfoliative syndrome 13. Prior intravitreal injections within 7 days of the surgery 14. IOP over 25mmHg under treatment 15. Best corrected visual acuity \< 1/10 16. Patient already included in the study for phakoexeresis 17. History of ophthalmic surgical complication (cystoid macular oedema, etc.) 18. Diabetes mellitus 19. Surdity 20. Pakinsondisease 21. Excessive anxiety 22. 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. 23. Known hypersensitivity to sulfonamides products or any of the components of the study medications or to test products Specific exclusion criteria for women 24. Pregnancy (positive pregnancy test), lactation 25. 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 26. Women not hysterectomized, not menopaused nor surgically sterilized. Exclusion criteria related to general conditions 27. Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent 28. Non-compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance) 29. Participation in anotherclinicalstudy 30. Already included once in this study 31. Ward of court 32. Patient not covered by the Social Security

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2023-01-18