NCT05470881

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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),

Detailed 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.

Conditions

• Myopia

Interventions

Type	Name	Description
DRUG	Atropine Sulfate	Administration of one drop QD on both eyes for 14 days.

Timeline

• Start date: 2022-08-20
• Primary completion: 2022-12-26
• Completion: 2022-12-26
• First posted: 2022-07-22
• Last updated: 2026-02-05
• Results posted: 2026-02-05

Locations

1 site across 1 country: Mexico