Clinical trial NCT06859476: Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes.
Official title: Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Ophthalmological Agent Toxicity
Keywords: Matricaria Recutita
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: 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
timeFrame: Day 0 (Basal visit), Day 8 (Final visit)
Secondary outcomes:
measure: Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of red eye
timeFrame: Day 0 (Basal visit), Day 8 (Final visit)
measure: Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of dry eye sensation.
timeFrame: Day 0 (Basal visit), Day 8 (Final visit)
measure: Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of eye irritation
timeFrame: Day 0 (Basal visit), Day 8 (Final visit)
measure: Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of sensation of eye discharge.
timeFrame: Day 0 (Basal visit), Day 8 (Final visit)
measure: Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of comfort with the application of the investigational product (IP).
timeFrame: Day 0 (Basal visit), Day 8 (Final visit)
Other outcomes:
measure: Safety Assessment:• Compare the incidence of adverse events (AEs) related to the interventions.
timeFrame: Day 0 (Basal visit), Day 8 (Final visit)
Locations:
Study officials:
References: