Overview
Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.
Status:
Completed
Completed
Trial end date:
2021-03-09
2021-03-09
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Sintetica SATreatments:
Chloroprocaine
Tetracaine
Criteria
Inclusion Criteria:1. Signed and dated informed consent
2. Male or female agedā„ 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