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Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution — PRO-230  

Myopia Clinical Trial

Official title:
Phase I Clinical Trial to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-230 When Applied to the Ocular Surface of Healthy Volunteers.

Clinical Trial Summary

Phase I Study to evaluate safety and tolerability of PRO-230 (atropine sulphate 0.05%) ophthalmic solution through evaluation of incidence of non-expected adverse events (AE), photophobia, pupillary diameter, incidence of expected adverse events, and best near corrected visual acuity (BNCVA)

Clinical Trial Description

A total of 29 healthy volunteers will apply PRO-230 ocular solution on both eyes QD (one time per day) for 14 days. The safety variables will include non expected AE, pupillary diameter and expected AE; tolerability variables will include incidence of photofobia, and BNCVA. Exploratory variables include best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal an conjunctival staining with fluorescein and lissamine green, vital signs (heart rate and blood pressure), and results of the Ocular Confort Index (OCI) questionnaire. The presence of non-expected AE < 10% will deem PRO-230 as safe; while an incidence of photophobia < 30% will deem PRO-230 as tolerable. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05481489
Study type Interventional
Source Laboratorios Sophia S.A de C.V.
Contact
Status Withdrawn
Phase Phase 1
Start date February 1, 2023
Completion date March 31, 2023
View Details
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