Phase 4
Completed N=167
Evaluation of Manzanilla® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes
Ophthalmological Agent Toxicity
Source: ClinicalTrials.gov NCT06859476 ↗
Enrolled (actual)
167
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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.
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. Informational only — not medical advice.