Chamomile eye drops challenge standard treatment for eye relief
NCT ID NCT06859476
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether Manzanilla Sophia®, a chamomile-based eye drop, is as good as Meticel Ofteno® 0.5% for relieving eye discomfort caused by other eye drops. 167 adults with eye irritation participated. The main goal was to see if the chamomile drops reduced eye fatigue scores by at least 20% compared to baseline, matching the standard treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Manzanilla Sophia® (chamomile ophthalmic solution)
- What this could lead to
- If it works, this could offer a natural alternative for soothing eye irritation caused by other eye drops.
- What could go wrong
- This is a small, completed Phase 4 trial testing non-inferiority, not superiority. The results may not apply to other types of eye discomfort, and the primary outcome is based on a new, adapted test.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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167 people
The number who actually took part.
- Started
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May 2025
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Unidad Clinica de Bioequivalencia (UNEBI), S de R.L de C.V.
Guadalajara, Jalisco, Mexico