Phase 4 N=167 Randomized Other

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

Ophthalmological Agent Toxicity

Bottom Line

View on ClinicalTrials.gov: NCT06859476 ↗

Enrolled (actual)

167

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: The Proportion of Participants Who Decreased ≥ 6 Points or the Equivalent of 20% or More in the Visual Analog Test Score Compared to Their Baseline — 74; 72 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Manzanilla Sophia® (Drug); Meticel Ofteno® 0.5% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Laboratorios Sophia S.A de C.V.
Primary completion: Sep 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY The Proportion of Participants Who Decreased ≥ 6 Points or the Equivalent of 20% or More in the Visual Analog Test Score Compared to Their Baseline	74; 72	—
SECONDARY Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Red Eye	15; 9; 68; 72; 1; 1	—
SECONDARY Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Dry Eye Sensation.	53; 55; 10; 8	—
SECONDARY Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Eye Irritation	54; 54; 13; 8	—
SECONDARY Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Sensation of Eye Discharge.	32; 38; 4; 2	—
SECONDARY Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Comfort With the Application of the Investigational Product (IP).	73; 68	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06859476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.