Evaluation of Manzanilla® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes (NCT06859476) | Clinical Trial Compass
CompletedPhase 4
Evaluation of Manzanilla® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes
Mexico167 participantsStarted 2025-05-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
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