Trial Outcomes & Findings for Evaluation of Manzanilla® and Meticel Ofteno® 0.5% for Providing a Relief Sensation to the Eyes (NCT NCT06859476)

Last Updated: 2026-04-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

167 participants

Primary outcome timeframe

Day 8 (Final visit)

Results posted on

2026-04-08

Participant Flow

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	84 84	83 83
Overall Study COMPLETED	83 83	81 81
Overall Study NOT COMPLETED	1 1	2 2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Manzanilla Sophia® n=84 Participants 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.	Meticel Ofteno® 0.5% n=82 Participants 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.	Total n=166 Participants Total of all reporting groups
Weight	77.90 kilograms STANDARD_DEVIATION 21.2 • n=84 Participants	72.0 kilograms STANDARD_DEVIATION 14.3 • n=82 Participants	74.94 kilograms STANDARD_DEVIATION 18.3 • n=166 Participants
Age, Continuous	42.79 years STANDARD_DEVIATION 15.0 • n=84 Participants	41.91 years STANDARD_DEVIATION 14.1 • n=82 Participants	42.69 years STANDARD_DEVIATION 14.8 • n=166 Participants
Sex: Female, Male Female	53 Participants n=84 Participants	54 Participants n=82 Participants	107 Participants n=166 Participants
Sex: Female, Male Male	31 Participants n=84 Participants	28 Participants n=82 Participants	59 Participants n=166 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Mexico	84 Participants n=84 Participants	82 Participants n=82 Participants	166 Participants n=166 Participants
Systolic blood pressure	112.77 millimeters of mercury (mmHg) STANDARD_DEVIATION 14.2 • n=84 Participants	111.48 millimeters of mercury (mmHg) STANDARD_DEVIATION 11.2 • n=82 Participants	112.18 millimeters of mercury (mmHg) STANDARD_DEVIATION 12.8 • n=166 Participants
Diastolic blood pressure	71.58 millimeters of mercury (mmHg) STANDARD_DEVIATION 7.4 • n=84 Participants	71.05 millimeters of mercury (mmHg) STANDARD_DEVIATION 7.0 • n=82 Participants	71.28 millimeters of mercury (mmHg) STANDARD_DEVIATION 7.2 • n=166 Participants
Heart rate	73.64 beats per minute STANDARD_DEVIATION 10.2 • n=84 Participants	72.60 beats per minute STANDARD_DEVIATION 10.6 • n=82 Participants	73.04 beats per minute STANDARD_DEVIATION 10.4 • n=166 Participants
Respiratory rate	18.1 breaths per minute STANDARD_DEVIATION 1.5 • n=84 Participants	17.91 breaths per minute STANDARD_DEVIATION 1.6 • n=82 Participants	17.98 breaths per minute STANDARD_DEVIATION 1.5 • n=166 Participants
Height	163.3 centimeters STANDARD_DEVIATION 9.0 • n=84 Participants	163.3 centimeters STANDARD_DEVIATION 8.8 • n=82 Participants	163.3 centimeters STANDARD_DEVIATION 8.8 • n=166 Participants

PRIMARY outcome

Timeframe: Day 8 (Final visit)

Population: The analysis for the primary efficacy variable was performed in the intention-to-treat (ITT) population with a total of 166 participants.

Outcome measures

Outcome measures
Measure	Meticel Ofteno® 0.5% n=82 Participants 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.	Manzanilla Sophia® n=84 Participants 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.
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	72 Participants	74 Participants

SECONDARY outcome

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

Population: The analysis for secondary outcome variables was performed in the per-protocol population

The presence of red eye (presence/absence) will be assessed based on direct observation by the investigator.

Outcome measures

Outcome measures
Measure	Meticel Ofteno® 0.5% n=81 Participants 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.	Manzanilla Sophia® n=83 Participants 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.
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Red Eye Basal visit · Red eye	9 Participants	15 Participants
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Red Eye Basal visit · No red eye	72 Participants	68 Participants
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Red Eye Final visit · Red eye	1 Participants	1 Participants
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Red Eye Final visit · No red eye	80 Participants	82 Participants

SECONDARY outcome

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

Population: The analysis for secondary outcome variables was performed in the per-protocol population (PP)

This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent.

Outcome measures

Outcome measures
Measure	Meticel Ofteno® 0.5% n=81 Participants 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.	Manzanilla Sophia® n=83 Participants 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.
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Dry Eye Sensation. Basal visit	55 Participants	53 Participants
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Dry Eye Sensation. Final visit	8 Participants	10 Participants

SECONDARY outcome

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

Population: The analysis for secondary outcome variables was performed in the per-protocol population (PP)

This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent.

Outcome measures

Outcome measures
Measure	Meticel Ofteno® 0.5% n=81 Participants 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.	Manzanilla Sophia® n=83 Participants 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.
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Eye Irritation Basal visit	54 Participants	54 Participants
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Eye Irritation Final visit	8 Participants	13 Participants

SECONDARY outcome

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

Population: The analysis for secondary outcome variables was performed in the per-protocol population (PP)

This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent.

Outcome measures

Outcome measures
Measure	Meticel Ofteno® 0.5% n=81 Participants 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.	Manzanilla Sophia® n=83 Participants 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.
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Sensation of Eye Discharge. Basal visit	38 Participants	32 Participants
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Sensation of Eye Discharge. Final visit	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 8 (Final visit)

Population: The analysis for secondary outcome variables was performed in the per-protocol population (PP) at the final study visit

This result was obtained by the principal investigator directly questioning the subject, and the response was recorded as present/absent.

Outcome measures

Outcome measures
Measure	Meticel Ofteno® 0.5% n=81 Participants 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.	Manzanilla Sophia® n=83 Participants 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.
Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Comfort With the Application of the Investigational Product (IP).	68 Participants	73 Participants

OTHER_PRE_SPECIFIED outcome

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

Population: The analysis for secondary outcome variables was performed in the safety population.

For this variable, only the number of adverse events classified as related to interventions in each group are compared.

Outcome measures

Outcome measures
Measure	Meticel Ofteno® 0.5% n=83 Participants 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.	Manzanilla Sophia® n=84 Participants 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.
Comparison of the Incidence of Adverse Events (AEs) Related to the Interventions Between Groups Related	45 number of events	48 number of events
Comparison of the Incidence of Adverse Events (AEs) Related to the Interventions Between Groups Unrelated	4 number of events	3 number of events

Adverse Events

Manzanilla Sophia®

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Meticel Ofteno® 0.5%

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Alejandra Sanchez-Ríos

Laboratorios Sophia S.A. de C.V.

Phone: 3330014500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Manzanilla Sophia® n=84 participants at risk 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.	Meticel Ofteno® 0.5% n=83 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/84 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	2.4% 2/83 • Number of events 2 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Immune system disorders Seasonal allergy	0.00% 0/84 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	1.2% 1/83 • Number of events 1 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Infections and infestations Dengue	0.00% 0/84 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	1.2% 1/83 • Number of events 1 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Eye disorders Sensation of a foreign body in the eyes	0.00% 0/84 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	1.2% 1/83 • Number of events 1 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Gastrointestinal disorders Oral hypoesthesia	0.00% 0/84 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	1.2% 1/83 • Number of events 1 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Eye disorders Photophobia	1.2% 1/84 • Number of events 1 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	0.00% 0/83 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Eye disorders Ocular hyperemia	1.2% 1/84 • Number of events 1 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	0.00% 0/83 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Eye disorders Asthenopia	0.00% 0/84 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	2.4% 2/83 • Number of events 2 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Eye disorders Eye irritation	31.0% 26/84 • Number of events 26 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	27.7% 23/83 • Number of events 23 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Eye disorders Itching in the eye	10.7% 9/84 • Number of events 9 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	8.4% 7/83 • Number of events 7 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Eye disorders Increased tearing	4.8% 4/84 • Number of events 4 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	1.2% 1/83 • Number of events 1 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Nervous system disorders Headache	4.8% 4/84 • Number of events 4 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	1.2% 1/83 • Number of events 1 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Eye disorders Blurred vision	3.6% 3/84 • Number of events 3 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	8.4% 7/83 • Number of events 7 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Eye disorders Eye pain	2.4% 2/84 • Number of events 2 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	1.2% 1/83 • Number of events 1 • The adverse events were recorded over an 11-day period, the duration of the clinical study.
Nervous system disorders Dysgeusia	1.2% 1/84 • Number of events 1 • The adverse events were recorded over an 11-day period, the duration of the clinical study.	1.2% 1/83 • Number of events 1 • The adverse events were recorded over an 11-day period, the duration of the clinical study.