Study of Non-inferiority Between Manzanilla Sophia® 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

• Status Verified: 2025-02
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• 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®	-
Meticel Ofteno® 0.5%	Meticel Ofteno® 0.5%	-

Primary Outcome Measures

Name	Time	Method
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	Day 0 (Basal visit), Day 8 (Final visit)	Score of the analogous visual test for eye fatigue (TE: screening and final visits).

Secondary Outcome Measures

Name	Time	Method
Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of red eye	Day 0 (Basal visit), Day 8 (Final visit)	Incidence of red eye (TE: screening and final visits)
Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of dry eye sensation.	Day 0 (Basal visit), Day 8 (Final visit)	Incidence of dry eye sensation (TE: screening and final visits).
Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of eye irritation	Day 0 (Basal visit), Day 8 (Final visit)	Incidence of eye irritation sensation (TE: screening and final visits).
Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of sensation of eye discharge.	Day 0 (Basal visit), Day 8 (Final visit)	Incidence of sensation of eye discharge (sleep) (TE: screening and final visits)
Compare Manzanilla Sophia® to 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)	Incidence of comfort with the application of the investigational product (IP) (TE: final visit).