Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes.

Eye Strain Clinical Trial

Official title: Clinical Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes.

Status Not yet recruiting

Clinical Trial Summary

This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing restful sensation to the eyes. This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions, the incidence of conjunctival hyperemia and the incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI).

Clinical Trial Description

Primary:

-Analog visual eyestrain test score

Secondary:

• Incidence of unexpected adverse events related to the interventions

• Incidence of conjunctival hyperemia

• Incidence of sensation of ocular dryness

• Incidence of ocular irritation

• Incidence of sensation of (sleep-crust)

• Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI) ;

Related Conditions & MeSH terms

• Asthenopia
• Eye Strain
• Sprains and Strains

• NCT number: NCT06373653
• Study type: Interventional
• Source: Laboratorios Sophia S.A de C.V.
• Contact: Alejandra Sanchez-Rios, MD
• Phone: 33 3001 4200
• Email: alejandra.sanchez@sophia.com.mx
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 30, 2024
• Completion date: December 30, 2024