NCT06379685

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

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.

• 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 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®.

Detailed 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

Conditions

• Dry Eye
• Dry Eyes Chronic
• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	PRO-190	Propylene glycol 0.3% - Polyethylene glycol 400 0.3%. Ophthalmic solution.
DRUG	Systane Ultra®	Propylene glycol 0.3% - Polyethylene glycol 400 0.4%. Ophthalmic solution.

Timeline

• Start date: 2025-12-30
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-04-23
• Last updated: 2025-03-19