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

NCT ID: NCT06859476

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Manzanilla Sophia®

Matricaria recutita 0.025%. One drop four times per day (QID), with a minimun interval of 3 hours between administrations, for 7 days.

Group Type: EXPERIMENTAL

Manzanilla Sophia®

Intervention Type: DRUG

Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.

Route of Administration: Ophthalmic.

Meticel Ofteno® 0.5%

Hydroxypropyl methylcellulose 0.5%. One drop QID, with a minimun interval of 3 hours between administrations, for 7 days.

Group Type: ACTIVE_COMPARATOR

Meticel Ofteno® 0.5%

Intervention Type: DRUG

Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.

Route of Administration: Ophthalmic.

Interventions

Manzanilla Sophia®

Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.

Route of Administration: Ophthalmic.

Intervention Type: DRUG

Meticel Ofteno® 0.5%

Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.

Route of Administration: Ophthalmic.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Ability to voluntarily provide signed informed consent.
• Able and willing to comply with the scheduled visits, treatment plan, and other study procedures.
• Be of legal age.
• Women of reproductive age who have not undergone bilateral tubal ligation or hysterectomy must ensure the continued use (initiated ≥ 30 days prior to signing the - - Informed Consent Form [ICF]) of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
• A score of ≥ 3 on the analogous visual test for eye fatigue in at least 4 of the included questions.

Exclusion Criteria

• Pregnant women, breastfeeding women, or those planning to become pregnant during the study period.
• Having participated in another clinical research study ≤ 30 days prior to the screening visit.
• Having previously participated in this study.
• Having only one functional eye.
• A history of current or past drug addiction or substance dependence within the last two years prior to signing the ICF.
• Current user of soft or hard contact lenses. They may be included if they suspend use during the study, and they must be lens-free for 15 days prior to inclusion.
• Known hypersensitivity to the components of the investigational products.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratorios Sophia S.A de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Alejandra Sanchez-Rios, MD

Role: CONTACT

alejandra.sanchez@sophia.com.mx

3330014200 ext. 1190

Other Identifiers

SOPHMAN-0824/IV

Identifier Type: -

Identifier Source: org_study_id