NCT06375343

Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive®

Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-240 Ophthalmic Solution Compared to Optive® on the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®.

Detailed description

The variables to be evaluated include: Primary (safety): \- Incidence of unexpected advere events (AE's) Secondary: * Changes in the ocular comfort index (OCI) score * Changes in intraocular pressure (IOP) * Changes in Best Corrected Visual Acuity (BCVA) * Adherence to treatment * Changes in tear film breakup time * Changes in fluorescein staining * Changes in lissamine green staining

Conditions

• Dry Eye Disease
• Dry Eye Sensation
• Ocular Surface Disease

Interventions

Type	Name	Description
DRUG	PRO-240	-Propylene glycol 0.3%, Polyethylene glycol 400 0.5%, and Glycerin 0.2%. Ophthalmic solution.
DRUG	Optive®	\- Carboxymethylcellulose 0.5%, and Glycerin 0.9%. Ophthalmic solution.

Timeline

• Start date: 2026-01-30
• Primary completion: 2027-01-30
• Completion: 2027-01-30
• First posted: 2024-04-19
• Last updated: 2025-03-19