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: * Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of red eye. * Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of dry eye sensation. * Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of eye irritation. * Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of sensation of eye discharge (sleep). * Compare Manzanilla Sophia® to Meticel Ofteno® 0.5% in the incidence of comfort with the application of the investigational product (IP). Safety Assessment: \- Compare the incidence of adverse events (AEs) related to the interventions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
167
Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic.
Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic.
Unidad Clinica de Bioequivalencia (UNEBI), S de R.L de C.V.
Guadalajara, Jalisco, Mexico
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.
Time frame: Day 8 (Final visit)
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.
Time frame: Day 0 (Basal visit), Day 8 (Final visit)
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.
Time frame: 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.
Time frame: Day 0 (Basal visit), Day 8 (Final visit)
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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.
Time frame: 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.
Time frame: Day 8 (Final visit)