NCT06370585

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (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 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.

Detailed 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.

Conditions

• Dry Eye Disease
• Ocular Surface Disease

Interventions

Type	Name	Description
DRUG	PRO-229	\- Dexpanthenol 2% and sodium hyaluronate 0.15% ophthalmic solution.
DRUG	Lagricel® Ofteno PF	\- Sodium hyaluronate 0.4%. Ophthalmic solution.

Timeline

• Start date: 2024-05-16
• Primary completion: 2024-07-25
• Completion: 2024-11-13
• First posted: 2024-04-17
• Last updated: 2025-03-04

Locations

1 site across 1 country: Mexico