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

NCT ID: NCT06373653

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-11
• Study Completion Date: 2025-02-11

Brief 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

Study Design

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

Study Groups

Manzanilla Sophia®

Matricaria recutita 0.025%, Ophthalmic solution.

• Dosage: 1 drop every 4 hours (4 daily applications [QID]), during 7 days.
• Route of administration: Topical ophthalmic.

Group Type: ACTIVE_COMPARATOR

Manzanilla Sophia®

Intervention Type: DRUG

Matricaria recutita 0.025%, Ophthalmic solution.

Meticel Ofteno®

Hypromellose 0.5%. Ophthalmic solution.

• Dosage: 1 drop every 4 hours (4 daily applications [QID]), during 7 days
• Route of administration: Topical ophthalmic.

Group Type: ACTIVE_COMPARATOR

Meticel Ofteno®

Intervention Type: DRUG

Hypromellose 0.5%, Ophthalmic solution.

Interventions

Manzanilla Sophia®

Matricaria recutita 0.025%, Ophthalmic solution.

Intervention Type: DRUG

Meticel Ofteno®

Hypromellose 0.5%, Ophthalmic solution.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Having the ability to voluntarily give their signed informed consent.
• Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
• Age ≥18 years.
• Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO [Tubal Ligation]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the informed consent form [ICF]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
• Present on the analog visual eyestrain test score ≥ 3 on at least 4 of the included questions.

Exclusion Criteria

• History of hypersensitivity to any of the components of the drugs under investigation.
• Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.
• In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.
• Having participated in any clinical research study 30 days prior to inclusion in this study.
• Having previously participated in this same study.
• Having a single functional eye.
• Having a history of drug addiction or drug dependence current or within the last two years prior to signing the informed consent.

Elimination Criteria:

• Withdrawal of their consent to participate in the study (informed consent form).
• Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and/or the sponsor, could affect the patient's fitness to safely continue with the study procedures.
• Non-tolerability or hypersensitivity to any of the drugs under investigation.

• 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

Other Identifiers

SOPHMAN-0922/IV

Identifier Type: -

Identifier Source: org_study_id