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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.
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:
Safety Assessment:
- Compare the incidence of adverse events (AEs) related to the interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manzanilla Sophia® | Drug | Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Red Eye | The presence of red eye (presence/absence) will be assessed based on direct observation by the investigator. | Day 0 (Basal visit), Day 8 (Final visit) |
| Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Dry Eye Sensation. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the Incidence of Adverse Events (AEs) Related to the Interventions Between Groups | For this variable, only the number of adverse events classified as related to interventions in each group are compared. | Day 0 (Basal visit), Day 8 (Final visit) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad Clinica de Bioequivalencia (UNEBI), S de R.L de C.V. | Guadalajara | Jalisco | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Manzanilla Sophia®: Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic. |
| FG001 | Meticel Ofteno® 0.5% | Hydroxypropyl methylcellulose 0.5%. One drop QID, with a minimun interval of 3 hours between administrations, for 7 days. Meticel Ofteno® 0.5%: Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Demographic characteristics were analyzed in the intention-to-treat (ITT) population.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Manzanilla Sophia®: Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis for the primary efficacy variable was performed in the intention-to-treat (ITT) population with a total of 166 participants. | Posted | Count of Participants | Participants | Day 8 (Final visit) |
The adverse events were recorded over an 11-day period, the duration of the clinical study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Manzanilla Sophia®: Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alejandra Sanchez-Ríos | Laboratorios Sophia S.A. de C.V. | 3330014500 | 1190 | alejandra.sanchez@sophia.com.mx |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2025 | Mar 9, 2026 | Prot_SAP_000.pdf |
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| Meticel Ofteno® 0.5% | Drug | Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic. |
|
This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent. |
| Day 0 (Basal visit), Day 8 (Final visit) |
| Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Eye Irritation | This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent. | 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. | This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent. | 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). | This result was obtained by the principal investigator directly questioning the subject, and the response was recorded as present/absent. | Day 8 (Final visit) |
| Meticel Ofteno® 0.5% |
Hydroxypropyl methylcellulose 0.5%. One drop QID, with a minimun interval of 3 hours between administrations, for 7 days. Meticel Ofteno® 0.5%: Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Demographic characteristics were analyzed in the intention-to-treat (ITT) population. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Demographic characteristics were analyzed in the intention-to-treat (ITT) population. | Count of Participants | Participants |
|
| Systolic blood pressure | Mean | Standard Deviation | millimeters of mercury (mmHg) |
|
| Diastolic blood pressure | Mean | Standard Deviation | millimeters of mercury (mmHg) |
|
| Heart rate | Mean | Standard Deviation | beats per minute |
|
| Respiratory rate | Mean | Standard Deviation | breaths per minute |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | centimeters |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 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. Manzanilla Sophia®: Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic. |
| OG001 | Meticel Ofteno® 0.5% | Hydroxypropyl methylcellulose 0.5%. One drop QID, with a minimun interval of 3 hours between administrations, for 7 days. Meticel Ofteno® 0.5%: Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic. |
|
|
|
| Secondary | Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Red Eye | The presence of red eye (presence/absence) will be assessed based on direct observation by the investigator. | The analysis for secondary outcome variables was performed in the per-protocol population | Posted | Count of Participants | Participants | Day 0 (Basal visit), Day 8 (Final visit) |
|
|
|
| Secondary | Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Dry Eye Sensation. | This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent. | The analysis for secondary outcome variables was performed in the per-protocol population (PP) | Posted | Count of Participants | Participants | Day 0 (Basal visit), Day 8 (Final visit) |
|
|
|
| Secondary | Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Eye Irritation | This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent. | The analysis for secondary outcome variables was performed in the per-protocol population (PP) | Posted | Count of Participants | Participants | Day 0 (Basal visit), Day 8 (Final visit) |
|
|
|
| Secondary | Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Sensation of Eye Discharge. | This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent. | The analysis for secondary outcome variables was performed in the per-protocol population (PP) | Posted | Count of Participants | Participants | Day 0 (Basal visit), Day 8 (Final visit) |
|
|
|
| Secondary | Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Comfort With the Application of the Investigational Product (IP). | This result was obtained by the principal investigator directly questioning the subject, and the response was recorded as present/absent. | The analysis for secondary outcome variables was performed in the per-protocol population (PP) at the final study visit | Posted | Count of Participants | Participants | Day 8 (Final visit) |
|
|
|
| Other Pre-specified | Comparison of the Incidence of Adverse Events (AEs) Related to the Interventions Between Groups | For this variable, only the number of adverse events classified as related to interventions in each group are compared. | The analysis for secondary outcome variables was performed in the safety population. | Posted | Number | number of events | Day 0 (Basal visit), Day 8 (Final visit) |
|
|
|
| 0 |
| 84 |
| 0 |
| 84 |
| 35 |
| 84 |
| EG001 | Meticel Ofteno® 0.5% | Hydroxypropyl methylcellulose 0.5%. One drop QID, with a minimun interval of 3 hours between administrations, for 7 days. Meticel Ofteno® 0.5%: Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic. | 0 | 83 | 0 | 83 | 35 | 83 |
| Itching in the eye | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Increased tearing | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ocular hyperemia | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dengue | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Sensation of a foreign body in the eyes | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Oral hypoesthesia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| Final visit |
|