NCT06373653

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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)

Conditions

• Eye Strain
• Eye Strain of Both Eyes

Interventions

Type	Name	Description
DRUG	Manzanilla Sophia®	Matricaria recutita 0.025%, Ophthalmic solution.
DRUG	Meticel Ofteno®	Hypromellose 0.5%, Ophthalmic solution.

Timeline

• Start date: 2025-02-11
• Primary completion: 2025-02-11
• Completion: 2025-02-11
• First posted: 2024-04-18
• Last updated: 2025-02-14