NCT06859476

Evaluation of Manzanilla® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue.

Detailed description

Primary Objective: Demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing a sensation of eye relief, through the score of an analogous visual test for eye fatigue. Secondary Objectives: Signs and Symptoms Evaluated: * Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of red eye. * Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of dry eye sensation. * Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of eye irritation. * Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of sensation of eye discharge (sleep). * Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of comfort with the application of the investigational product (IP). Safety Assessment: \- Compare the incidence of adverse events (AEs) related to the interventions.

Conditions

• Ophthalmological Agent Toxicity

Interventions

Type	Name	Description
DRUG	Manzanilla Sophia®	Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic.
DRUG	Meticel Ofteno® 0.5%	Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic.

Timeline

• Start date: 2025-05-23
• Primary completion: 2025-09-23
• Completion: 2025-09-23
• First posted: 2025-03-05
• Last updated: 2026-04-08
• Results posted: 2026-04-08

Locations

1 site across 1 country: Mexico