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NOT YET RECRUITING
NCT06379685
PHASE1

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

Sponsor: Laboratorios Sophia S.A de C.V.

View on ClinicalTrials.gov

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®.

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-12-30

Completion Date

2026-12-30

Last Updated

2025-03-19

Healthy Volunteers

Yes

Interventions

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.