NCT04685538

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: Sintetica SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Chloroprocaine 3%	Administration: three IMP drops instillation as follow: * 1st Drop instillation, then wait for 5 minutes * Eye Disinfection, then wait for 2 minutes * 2nd Drop instillation, then wait for 1 minute * 3rdDrop instillation, then wait for 1 minute * Start of Surgery.
DRUG	Tetracaine 0.5%	Administration: three IMP drops instillation as follow: * 1st Drop instillation, then wait for 5 minutes * Eye Disinfection, then wait for 2 minutes * 2nd Drop instillation, then wait for 1 minute * 3rdDrop instillation, then wait for 1 minute * Start of Surgery.

Timeline

• Start date: 2020-09-09
• Primary completion: 2021-03-01
• Completion: 2021-03-09
• First posted: 2020-12-28
• Last updated: 2023-01-18
• Results posted: 2022-10-27

Locations

27 sites across 3 countries: Italy, Slovakia, Spain