NCT06352541

Study Evaluating PRO-232 an Ophthalmic Solution Compared to Placebo.

Phase I Clinical Study, Evaluating Safety and Tolerability of PRO-232 an Ophthalmic Solution, Versus Placebo, When Applied to the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a phase I study evaluating safety and tolerability through the incidence of unexpected adverse events and IOP measurement, as well as through the incidence of stinging after its administration, compared to placebo.

Detailed description

The variables to be evaluated include: Primary (safety): * Unexpected adverse events * IOP Primary (tolerability): \- Stinging Secondary (safety): * Expected and related adverse events * BCVA * Ocular surface stining Secondary (tolerability): \- Other ocular symptoms (foreign body sensation and tearing) The operational definition states a difference under 15% in order to consider non inferior the safety and tolerability profile of PRO-232 compared to placebo.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PRO-232	Moxifloxacin 0.5% and Dexamethasone Phosphate 0.1%
OTHER	Placebo	Vehicle Control, ophthalmic solution

Timeline

• Start date: 2024-02-08
• Primary completion: 2024-05-28
• Completion: 2024-05-28
• First posted: 2024-04-08
• Last updated: 2026-04-16

Locations

1 site across 1 country: Mexico