Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.

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.

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.

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.

Follow-up visit/phone visit (Visit 3, Day 2):

Concomitant ocular and non-ocular treatments, AEs, and patient global satisfaction will be assessed.

Final visit (Visit 4, Day 8 ± 1 day):

Concomitant ocular and non-ocular treatments, ocular symptoms, best far corrected visual acuity in both eyes, endothelial cell count, corneal thickness, blood pressure and heart rate, and AEs will be assessed. Slit lamp examination and fluorescein test, IOP in both eyes, and fundoscopy will be performed.

Optional visit/phone visit (Visit 5, Day 28 ± 3 days):

Concomitant ocular and non-ocular treatments and AEs resolution will be assessed.

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