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

Laboratorios Sophia

Status and phase: Not yet enrolling; Phase 4

Conditions: Ophthalmological Agent Toxicity

Treatments: Drug: Meticel Ofteno® 0.5%; Drug: Manzanilla Sophia®

Study type: Interventional

Funder types: Industry

Identifiers

NCT06859476

SOPHMAN-0824/IV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

Manzanilla Sophia®

Experimental group

Description:

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

Treatment:

Drug: Manzanilla Sophia®

Meticel Ofteno® 0.5%

Active Comparator group

Description:

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

Treatment:

Drug: Meticel Ofteno® 0.5%