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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Matricaria recutita 0.025%, Ophthalmic solution.
Hypromellose 0.5%, Ophthalmic solution.
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).
Time frame: Days: 0 (Basal Visit) and 8 (Final Visit).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Incidence of sensation of (sleep-crust)
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The subject will be questioned directly. Sleep crust is defined as the subjective sensation of the presence of eye discharge.
Time frame: 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.
Time frame: Day 8 (Final Visit)