Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor's decision.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manzanilla Sophia® | Active Comparator | Matricaria recutita 0.025%, Ophthalmic solution.
|
|
| Meticel Ofteno® | Active Comparator | Hypromellose 0.5%. Ophthalmic solution.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manzanilla Sophia® | Drug | Matricaria recutita 0.025%, Ophthalmic solution. |
| |
| 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). |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Elimination Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001248 | Asthenopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Phase IV non-inferiority, open-label, controlled, comparative, multicenter, clinical study.
Not provided
Not provided
Open-label,
Not provided
| Meticel Ofteno® |
| Drug |
Hypromellose 0.5%, Ophthalmic solution. |
|
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) |