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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Eye Strain; Eye Strain of Both Eyes
• Intervention / Treatment: Drug: Manzanilla Sophia®; Drug: Meticel Ofteno®

Detailed Description

Primary:

-Analog visual eyestrain test score

Secondary:

• Incidence of unexpected adverse events related to the interventions
• Incidence of conjunctival hyperemia
• Incidence of sensation of ocular dryness
• Incidence of ocular irritation
• Incidence of sensation of (sleep-crust)
• Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 participated in any clinical research study 30 days prior to inclusion in this study.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manzanilla Sophia®; 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®; Matricaria recutita 0.025%, Ophthalmic solution.
Active Comparator: Meticel Ofteno®; 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®; Hypromellose 0.5%, Ophthalmic solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of unexpected adverse events related to the interventions	Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.	Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 10 (Safety Call)
Incidence of conjunctival hyperemia	Any signs of conjunctival hyperemia in between interventions. Conjunctival hyperemia is defined as the red appearance secondary to vasodilatation of the conjunctival blood vessels of variable intensity.	Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Incidence of sensation of ocular dryness.	The subject will be questioned directly. Ocular dryness is defined as the subjective sensation of dry eye.	Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Incidence of ocular irritation	The subject will be questioned directly. Ocular irritation is defined as the subjective sensation of eye irritation.	Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Incidence of sensation of (sleep-crust)	The subject will be questioned directly. Sleep crust is defined as the subjective sensation of the presence of eye discharge.	Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)	The subject will be questioned directly by de PI during the final visit.	Day 8 (Final Visit)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): February 11, 2025
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): February 11, 2025

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Eye Diseases; Sprains and Strains; Asthenopia
• Other Study ID Numbers: SOPHMAN-0922/IV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No