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

NCT06859476 | Completed Phase 4 Results DMC

• 1 other identifier: SOPHMAN-0824/IV
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Ophthalmological Agent Toxicity

Keywords

Matricaria Recutita

Outcome Measures

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

  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.

  Day 8 (Final visit)

Secondary Outcomes (5)

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

  Day 0 (Basal visit), Day 8 (Final visit)

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

  Day 0 (Basal visit), Day 8 (Final visit)

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

  Day 0 (Basal visit), Day 8 (Final visit)

• 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)

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

  Day 8 (Final visit)

Other Outcomes (1)

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

  Day 0 (Basal visit), Day 8 (Final visit)

Study Arms (2)

Manzanilla Sophia®

EXPERIMENTAL

Matricaria recutita 0.025%. One drop four times per day (QID), with a minimun interval of 3 hours between administrations, for 7 days.

Drug: Manzanilla Sophia®

Meticel Ofteno® 0.5%

ACTIVE COMPARATOR

Hydroxypropyl methylcellulose 0.5%. One drop QID, with a minimun interval of 3 hours between administrations, for 7 days.

Drug: Meticel Ofteno® 0.5%

Interventions

Manzanilla Sophia® DRUG

Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic.

Manzanilla Sophia®

Meticel Ofteno® 0.5% DRUG

Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic.

Meticel Ofteno® 0.5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Known hypersensitivity to the components of the investigational products.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (1)

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

Guadalajara, Jalisco, Mexico

Location

Results Point of Contact

• Title: Alejandra Sanchez-Ríos
• Organization: Laboratorios Sophia S.A. de C.V.

alejandra.sanchez@sophia.com.mx

3330014500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: May 23, 2025
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2026-03

Locations

ME (1)