| Primary | Conjunctival Hyperemia (CH) | Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological. | statistical analysis by protocol (PP) | Posted | | Number | | eyes | | will be evaluated at the end of the treatment at the final visit (day 21) | eyes | eyes | | ID | Title | Description |
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| OG000 | PRO-155 | Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014 Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac | | OG001 | Placebo | Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac |
| | Units | Counts |
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| Participants | | | eyes | |
| | Title | Denominators | Categories |
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| Normal | | | | Very mild | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Chi-squared, Corrected | | 0.133 | | | | | | | | | | | | | | Non-Inferiority | it is considered not inferior if the differences between the groups do not exceed 20%. | |
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| Primary | Breakup Time (BUT) | breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds. | Statistical analysis was performed by protocol (PP) | Posted | | Mean | Standard Deviation | seconds | | will be evaluated at the end of the treatment at the final visit (day 21) | eyes | eyes | | ID | Title | Description |
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| OG000 | PRO-155 | Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014 Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac | | OG001 | Placebo | Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac |
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| Secondary | Epithelial Defects (ED) Green Lissamine | The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects. | | Posted | | Count of Units | | eyes | | will be evaluated at the end of the treatment at the final visit (day 21) | eyes | eyes | | ID | Title | Description |
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| OG000 | PRO-155 | Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014 Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac | | OG001 | Placebo | Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac |
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| Secondary | Intraocular Pressure (IOP) | the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg | the statistical analysis was carried out by protocol (PP) | Posted | | Mean | Standard Deviation | mmHg | | will be evaluated at the end of the treatment at the final visit (day 21) | eyes | eyes | | ID | Title | Description |
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| OG000 | PRO-155 | Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014 Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac | | OG001 | Placebo | Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac |
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| Secondary | Presence of Adverse Events (EAS) | primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. Adverse events that are reported until the safety call to the 36th day of the study will be considered for this variable | The analysis of adverse events was done by intention to treat (ITT) | Posted | | Count of Participants | | Participants | | will be evaluated at the end of the treatment at the final visit (day 36) | | | | ID | Title | Description |
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| OG000 | PRO-155 | Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014 Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac | | OG001 | Placebo | Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac |
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| Secondary | Visual Capacity | The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20. | | Posted | | Mean | Standard Deviation | LogMAR | | will be evaluated at the end of the treatment at the final visit (day 21) | eyes | eyes | | ID | Title | Description |
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| OG000 | PRO-155 | Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014 Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac | | OG001 | Placebo | Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac |
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| Secondary | Number of Eyes With Chemosis | In a normal eye there is no presence of chemosis (it is a sign of irritation of the eye, in which the outer covering of the eye can look like a large blister) its presence indicates a pathological state and it will be evaluated if the subjects present it. The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent. | the statistical analysis was carried out by protocol (PP) | Posted | | Count of Units | | eyes | | will be evaluated at the end of the treatment at the final visit (day 21) | eyes | eyes | | ID | Title | Description |
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| OG000 | PRO-155 | Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014 Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac | | OG001 | Placebo | Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac |
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| Secondary | Number of Eyes With Foreign Body Sensation (FBS) | Foreign body sensation will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent. | the statistical analysis was carried out by protocol (PP) | Posted | | Count of Units | | eyes | | will be evaluated at the end of the treatment at the final visit (day 21) | eyes | eyes | | ID | Title | Description |
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| OG000 | PRO-155 | Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014 Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac | | OG001 | Placebo | Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac |
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| Secondary | Epithelial Defects (ED) Fluorescein Stain | The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects. | the statistical analysis was carried out by protocol (PP) | Posted | | Count of Units | | eyes | | will be evaluated at the end of the treatment at the final visit (day 21) | eyes | eyes | | ID | Title | Description |
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| OG000 | PRO-155 | Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014 Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac | | OG001 | Placebo | Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac |
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| Other Pre-specified | Number of Eyes With Ocular Burning (OB) | primary tolerability variable Ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time. | the statistical analysis was carried out by protocol (PP) | Posted | | Count of Units | | eyes | | will be evaluated at the end of the treatment at the final visit (day 21) | eyes | eyes | | ID | Title | Description |
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| OG000 | PRO-155 | Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days PRO-155: PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014 Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac | | OG001 | Placebo | Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac Placebo: The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac |
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