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Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201 — PRO-201  

Myopia Clinical Trial

Official title:
Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-201 Ophthalmic Solution Applied on the Ocular Surface of Healthy Volunteers.

Clinical Trial Summary

Evaluation of the safety and tolerability of PRO-201 (0.01% sulfate atropine) after its instillation on the ocular surface of healthy volunteers through the following variables: unexpected adverse events incidence and photophobia (primary outcome variables); as well as pupillary diameter, expected adverse events incidence, best near corrected visual acuity (BNCVA), best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal and conjunctival staining, heart rate, blood pressure and ocular confort index (OCI),

Clinical Trial Description

A total of 29 healthy volunteers will be enrolled in this study. They will receive one drop of the investigation product PRO-201 (0.01% atropine sulfate) once a day (QD) for a total of 14 days on both eyes. A final safety call will be performed one week after the last day of product application. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05470881
Study type Interventional
Source Laboratorios Sophia S.A de C.V.
Contact
Status Completed
Phase Phase 1
Start date August 20, 2022
Completion date December 26, 2022
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