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NCT06859476 | NOT YET RECRUITING | Ophthalmological Agent Toxicity

Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes.
Sponsor:

LABORATORIOS Sophia S.A de C.V.

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.

Condition or disease

Ophthalmological Agent Toxicity

Intervention/treatment

Manzanilla Sophia®

Meticel Ofteno® 0.5%

Phase

PHASE4

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 168 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes.
Actual Study Start Date : 2025-08-31
Estimated Primary Completion Date : 2026-08-31
Estimated Study Completion Date : 2026-10-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes.

Location Details

NCT06859476

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