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Completed

NCT Number: NCT06859476

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

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.

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Key information

Conditions

Ophthalmological Agent Toxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Unidad Clinica de Bioequivalencia (UNEBI), S de R.L de C.V.

Guadalajara, Jalisco, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manzanilla Sophia®

Drug

Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.

Route of Administration: Ophthalmic.

Meticel Ofteno® 0.5%

Drug

Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.

Route of Administration: Ophthalmic.

Primary outcomes

  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

    Time frame: Day 8 (Final visit)

    To 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. Based on other tools previously used for the assessment of eye fatigue, the visual analog test for eye fatigue used in this protocol is adapted and created. This test includes the following questions: "Have you had a headache?", "Have you had eye strain?", "Do you have gritty sensation in your eyes?", "Have your eyes been itchy?", "How would you describe your clarity of sight?", "Do you feel any discomfort when you fix your eyes?". Each of these questions will be answered according to a Likert scale of 1-5. The sum of the answers, the total score, will be measured in a scale from 6 to 30. A higher score is a a worse outcome for this variable.

Secondary outcomes

  1. Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Red Eye

    Time frame: Day 0 (Basal visit), Day 8 (Final visit)

    The presence of red eye (presence/absence) will be assessed based on direct observation by the investigator.

  2. Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Dry Eye Sensation.

    Time frame: Day 0 (Basal visit), Day 8 (Final visit)

    This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent.

  3. Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Eye Irritation

    Time frame: Day 0 (Basal visit), Day 8 (Final visit)

    This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent.

  4. Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Sensation of Eye Discharge.

    Time frame: Day 0 (Basal visit), Day 8 (Final visit)

    This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent.

  5. Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Comfort With the Application of the Investigational Product (IP).

    Time frame: Day 8 (Final visit)

    This result was obtained by the principal investigator directly questioning the subject, and the response was recorded as present/absent.

Other outcomes

  1. Comparison of the Incidence of Adverse Events (AEs) Related to the Interventions Between Groups

    Time frame: Day 0 (Basal visit), Day 8 (Final visit)

    For this variable, only the number of adverse events classified as related to interventions in each group are compared.

Sponsors and collaborators

Lead sponsor

Laboratorios Sophia S.A de C.V.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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