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

Bacterial Conjunctivitis Clinical Trial

Official title:
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.

Clinical Trial 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®.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06363292
Study type Interventional
Source Laboratorios Sophia S.A de C.V.
Contact Alejandra Sanchez-Rios, MD
Phone 33 3001 4200
Email alejandra.sanchez@sophia.com.mx
Status Recruiting
Phase Phase 1
Start date January 30, 2024
Completion date May 30, 2024
View Details
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