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

Phase 4

Not yet recruiting

• Conditions: Ophthalmological Agent Toxicity
• Interventions: Drug: Manzanilla Sophia®; Drug: Meticel Ofteno® 0.5%

• Registration Number: NCT06859476
• Lead 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.

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 Timeline

• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Study First Posted: 2025-03-05
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-15
• Study Start: 2025-08-31
• Primary Completion: 2026-08-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manzanilla Sophia®	Manzanilla Sophia®	Matricaria recutita 0.025%. One drop four times per day (QID), with a minimun interval of 3 hours between administrations, for 7 days.
Meticel Ofteno® 0.5%	Meticel Ofteno® 0.5%	Hydroxypropyl methylcellulose 0.5%. One drop QID, with a minimun interval of 3 hours between administrations, for 7 days.

Primary Outcome Measures

Name	Time	Method
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	Day 0 (Basal visit), Day 8 (Final visit)	Score of the 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 Outcome Measures

Name	Time	Method
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the incidence of red eye	Day 0 (Basal visit), Day 8 (Final visit)	Number of cases of red eye
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the incidence of dry eye sensation.	Day 0 (Basal visit), Day 8 (Final visit)	Number of cases of dry eye sensation
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the incidence of eye irritation	Day 0 (Basal visit), Day 8 (Final visit)	Number of cases of eye irritation sensation
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the incidence of sensation of eye discharge.	Day 0 (Basal visit), Day 8 (Final visit)	Number of cases of sensation of eye discharge (sleep)
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the incidence of comfort with the application of the investigational product (IP).	Day 0 (Basal visit), Day 8 (Final visit)	Number of cases of comfort after the application of the investigational product (IP)