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

NCT06373653 | Withdrawn Phase 4 DMC

• 1 other identifier: SOPHMAN-0922/IV
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing restful sensation to the eyes. This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions, the incidence of conjunctival hyperemia and the incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI).

Conditions

Eye Strain; Eye Strain of Both Eyes

Outcome Measures

Primary Outcomes (1)

• Analog visual eyestrain test score

  The PI will evaluate the analog visual eyestrain test score by applying a direct questionnaire to the subject and allowing the subject to answer it calmly without any pressure. The analog visual test score is a questionnaire designed to establish the degree of eyestrain (fatigue) according to its symptomatology. This questionnaire will be as follows for frequency: never (1), sometimes (2), 50% of the time (3), almost all the time (4) and all the time (5).

  Days: 0 (Basal Visit) and 8 (Final Visit).

Secondary Outcomes (6)

• Incidence of unexpected adverse events related to the interventions

  Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 10 (Safety Call)

• Incidence of conjunctival hyperemia

  Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)

• Incidence of sensation of ocular dryness.

  Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)

• Incidence of ocular irritation

  Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)

• Incidence of sensation of (sleep-crust)

  Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)

Study Arms (2)

Manzanilla Sophia®

ACTIVE COMPARATOR

Matricaria recutita 0.025%, Ophthalmic solution. * Dosage: 1 drop every 4 hours (4 daily applications \[QID\]), during 7 days. * Route of administration: Topical ophthalmic.

Drug: Manzanilla Sophia®

Meticel Ofteno®

ACTIVE COMPARATOR

Hypromellose 0.5%. Ophthalmic solution. * Dosage: 1 drop every 4 hours (4 daily applications \[QID\]), during 7 days * Route of administration: Topical ophthalmic.

Drug: Meticel Ofteno®

Interventions

Manzanilla Sophia® DRUG

Matricaria recutita 0.025%, Ophthalmic solution.

Manzanilla Sophia®

Meticel Ofteno® DRUG

Hypromellose 0.5%, Ophthalmic solution.

Meticel Ofteno®

Eligibility Criteria

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

You may qualify if:

• Having the ability to voluntarily give their signed informed consent.
• Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
• Age ≥18 years.
• Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO \[Tubal Ligation\]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the informed consent form \[ICF\]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
• Present on the analog visual eyestrain test score ≥ 3 on at least 4 of the included questions.

You may not qualify if:

• History of hypersensitivity to any of the components of the drugs under investigation.
• Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.
• In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.
• Having previously participated in this same study.
• Having a single functional eye.
• Having a history of drug addiction or drug dependence current or within the last two years prior to signing the informed consent.
• Elimination Criteria:
• Withdrawal of their consent to participate in the study (informed consent form).
• Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and/or the sponsor, could affect the patient's fitness to safely continue with the study procedures.
• Non-tolerability or hypersensitivity to any of the drugs under investigation.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Asthenopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label,
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase IV non-inferiority, open-label, controlled, comparative, multicenter, clinical study.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: February 11, 2025
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share