CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 338 enrolled
Drug / intervention
Chloroprocaine 3% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04685538
NCT04685538Phase 3Completed
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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.

Sintetica SA·interventional·Posted Dec 28, 2020·Updated Jan 18, 2023

In Brief

A Phase 3 clinical trial evaluating Chloroprocaine 3% and Tetracaine 0.5% for Cataract. Completed, enrolled 338 participants across 27 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
CountriesItaly, Slovakia, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedDec 28, 2020
Enrollment StartSep 9, 2020
Primary CompletionMar 1, 2021
Study CompletionMar 9, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.5 years ago

Interventions

Chloroprocaine 3%drug

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.

Tetracaine 0.5%drug

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.