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Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.

NCT04685538 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2023-01-18

Study results available
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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.

Conditions

  • Cataract

Interventions

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.

Sponsors & Collaborators

  • Sintetica SA

    lead INDUSTRY

Principal Investigators

  • Jorge Alio, MD · Vissum Alicante, Calle del Cabañal 1, 03016 Alicante, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2021-03-01
Completion
2021-03-09

Countries

  • Italy
  • Slovakia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04685538 on ClinicalTrials.gov