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Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.

Dry Eye Clinical Trial

Official title:
Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers.

Clinical Trial Summary

This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®.

Clinical Trial Description

The variables to be evaluated include: Primary (safety): Incidence Unexpected Related Adverse Reactions Secondary: Changes in the ocular comfort index (OCI) score in between interventions Changes in Best Corrected Visual Acuity (BCVA) Changes in tear film breakup time Changes in intraocular pressure (IOP) Changes in the integrity of the ocular surface (fluorescein staining) Changes in lissamine green staining ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06379685
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 Not yet recruiting
Phase Phase 1
Start date September 30, 2024
Completion date April 30, 2025
View Details
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