NCT06363292

Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects

Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (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 clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, compared to VIGAMOXI®.

Detailed description

This is a Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial. The variables to be evaluated include: Primary (safety): * Incidence of unexpected adverse events related to the interventions * Incidence of conjunctival hyperemia and chemosis * Changes in Best Corrected Visual Acuity (BCVA) assessed with Snellen chart * Changes in ocular surface integrity using fluorescein staining, using the standard Oxford scale. Primary (tolerability): \- Changes in the ocular comfort index (OCI) score Secondary (safety): \- Incidence of unexpected adverse events related to the interventions(excluding conjunctival hyperemia and/or chemosis). Secondary (tolerability): \- Presence of other ocular symptoms (burning, foreign body sensation, pruritus and lacrimation).

Conditions

• Ophthalmological Agent Toxicity
• Bacterial Conjunctivitis

Interventions

Type	Name	Description
DRUG	PRO-231	Moxifloxacin 0.5% Ophthalmic solution.
DRUG	VIGAMOXI®	Moxifloxacin 0.5% Ophthalmic solution.

Timeline

• Start date: 2024-01-30
• Primary completion: 2024-05-28
• Completion: 2024-05-28
• First posted: 2024-04-12
• Last updated: 2025-06-15
• Results posted: 2025-06-15

Locations

1 site across 1 country: Mexico