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Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers

Healthy Subjects Clinical Trial

Official title:
A Phase I/II, Randomized, Placebo-controlled, Double-masked, Efficacy, Safety and Local Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers

Clinical Trial Summary

The study evaluate the efficacy, safety and local tolerability of Chloroprocaine 3% ophthalmic gel as compared to matching placebo in healthy subjects.

Clinical Trial Description

One hundred and five (105) healthy male and female subjects will be randomised in a 4:1 ratio to receive a single ocular instillation of Chloroprocaine 3% ophthalmic gel or matching placebo (vehicle) (84 subjects will receive chloroprocaine and 21 subjects will receive placebo). The assigned investigational product (3 drops) will be instilled in the right eye of each subject. Administrations will be performed at the clinical centre by the Investigator or his deputy on study day 1. For each administration, the 3 drops will be instilled at a 1 min ± 15 sec interval. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04779606
Study type Interventional
Source Sintetica SA
Contact
Status Completed
Phase Phase 1/Phase 2
Start date June 16, 2020
Completion date October 20, 2020
View Details
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