Ophthalmological Agent Toxicity
Conditions
Keywords
Matricaria Recutita
Brief summary
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.
Detailed description
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.
Interventions
Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic.
DRUGMeticel Ofteno® 0.5%
Ophthalmic solution. Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. Route of Administration: Ophthalmic.
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ability to voluntarily provide signed informed consent. * Able and willing to comply with the scheduled visits, treatment plan, and other study procedures. * Be of legal age. * Women of reproductive age who have not undergone bilateral tubal ligation or hysterectomy must ensure the continued use (initiated ≥ 30 days prior to signing the - - Informed Consent Form \[ICF\]) of a hormonal contraceptive method or intrauterine device (IUD) during the study period. * A score of ≥ 3 on the analogous visual test for eye fatigue in at least 4 of the included questions.
Exclusion criteria
* Pregnant women, breastfeeding women, or those planning to become pregnant during the study period. * Having participated in another clinical research study ≤ 30 days prior to the screening visit. * Having previously participated in this study. * Having only one functional eye. * A history of current or past drug addiction or substance dependence within the last two years prior to signing the ICF. * Current user of soft or hard contact lenses. They may be included if they suspend use during the study, and they must be lens-free for 15 days prior to inclusion. * Known hypersensitivity to the components of the investigational products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 8 (Final visit) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Red Eye | Day 0 (Basal visit), Day 8 (Final visit) | The presence of red eye (presence/absence) will be assessed based on direct observation by the investigator. |
| Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Dry Eye Sensation. | Day 0 (Basal visit), Day 8 (Final visit) | This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent. |
| Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Eye Irritation | Day 0 (Basal visit), Day 8 (Final visit) | This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent. |
| Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Sensation of Eye Discharge. | Day 0 (Basal visit), Day 8 (Final visit) | This symptom was obtained by direct questioning of the subject by the principal investigator, and the response was recorded as present/absent. |
| Comparison of Manzanilla Sophia® and Meticel Ofteno® 0.5% in the Incidence of Comfort With the Application of the Investigational Product (IP). | Day 8 (Final visit) | This result was obtained by the principal investigator directly questioning the subject, and the response was recorded as present/absent. |
Countries
Mexico
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.69 years STANDARD_DEVIATION 14.8 |
| Diastolic blood pressure | 71.28 millimeters of mercury (mmHg) STANDARD_DEVIATION 7.2 |
| Heart rate | 73.04 beats per minute STANDARD_DEVIATION 10.4 |
| Height | 163.3 centimeters STANDARD_DEVIATION 9 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Mexico | 166 Participants |
| Respiratory rate | 17.91 breaths per minute STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 28 Participants |
| Systolic blood pressure | 112.77 millimeters of mercury (mmHg) STANDARD_DEVIATION 14.2 |
| Weight | 74.94 kilograms STANDARD_DEVIATION 18.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 83 |
| other Total, other adverse events | 35 / 84 | 35 / 83 |
| serious Total, serious adverse events | 0 / 84 | 0 / 83 |
Outcome results
None listed