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Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF

Dry Eye Disease Clinical Trial

Official title:
Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF in Clinically Healthy Subjects

Clinical Trial Summary

This is a phase I study evaluating safety and tolerability of PRO-229 ophthalmic solution through he incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), incidence of chemosis, and changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale compared to Lagricel® Ofteno PF in clinically healthy subjects.

Clinical Trial Description

The variables to be evaluated include: Primary objective: - To evaluate the safety and tolerability of PRO-229 ophthalmic solution compared to Lagricel® Ofteno PF in clinically healthy subjects. Specific objective: - To compare the safety of PRO-229 formulation compared to Lagricel® Ofteno PF through the incidence of adverse events related to both investigational products. Secondary Objectives: - To compare the safety of vs. PRO-229 formulation compared to Lagricel® Ofteno PF by changes in Best Corrected Visual Acuity (BCVA). - To compare the safety of PRO-229 formulation compared to Lagricel® Ofteno PF by changes in ocular surface staining assessed with the the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale. - To compare the safety of PRO-229 formulation compared to Lagricel® Ofteno PF by the incidence of chemosis. - To compare the tolerability of PRO-229 formulation compared to Lagricel® Ofteno PF by changes in conjunctival hyperemia grades 3 or 4. - To ompare the tolerability of PRO-229 formulation compared to Lagricel® Ofteno Ophthalmic PF by adherence to treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06370585
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 May 30, 2024
Completion date September 30, 2024
View Details
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