drugset / Trial / NCT06379685

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

NCT06379685

Phase 1 Not yet recruiting 32 enrolled Laboratorios Sophia S.A de C.V.
RandomizedParallel-groupDouble-blindTreatment

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®.

Timeline

Start
2025-12-30
Primary completion
2026-12-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Polyethylene glycol 400 Unknown 0.3 % Other
Subject Polyethylene glycol 400 Unknown 0.4 % Other
Subject Propylene Glycol Small molecule 0.3 % Other

Indications