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Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus SophixÃn Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects.
Goals:
To evaluate the safety and tolerability of the formulation PRO-174 manufactured by Laboratorios Sophia, S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-174 presents a safety and tolerability profile similar to the comparator in healthy subjects.
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus SophixÃn Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects.
Goals:
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Number of patients:
30 subjects, divided into 2 groups [15 subjects (30 eyes) exposed per group]
Test product, dose and route of administration, lot number:
Duration of treatment: 7 days
Statistical methodology:
The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out through the Mann-Whitney U test for the quantitative variables for the difference between the groups. The intra-group difference will be made with the Wilcoxon rank test. The difference between the qualitative variables will be analyzed by means of X2 (Chi2). An alpha ≤ 0.05 will be considered significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-174 | Experimental | Active ingredient: Levofloxacin 0.5% o Dosage: 1 drop in both eyes, 8 times a day during the waking period |
|
| SophixÃn Ofteno® | Active Comparator | o Dosage: 1 drop in both eyes, 8 times a day during the waking period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-174 | Drug | Pharmaceutical form: ophthalmic solution
|
| Measure | Description | Time Frame |
|---|---|---|
| Number 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. | during the 12 days of evaluation, including the safety call (day 12). |
| 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. | will be evaluated at the end of the treatment at the final visit (day 7) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | will be evaluated at the end of the treatment at the final visit (day 7) |
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Inclusion Criteria:
Exclusion Criteria:
General criteria
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| Name | Affiliation | Role |
|---|---|---|
| Leopoldo Baiza Durán, MD | Laboratorios Sophia S.A de C.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Medical Offices | Guadalajara | Jalisco | 44650 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34707360 | Derived | Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PRO-174 | Active ingredient: Levofloxacin 0.5% o Dosage: 1 drop in both eyes, 8 times a day during the waking period PRO-174: Pharmaceutical form: ophthalmic solution
|
| FG001 | SophixÃn Ofteno® | o Dosage: 1 drop in both eyes, 8 times a day during the waking period SophixÃn Ofteno®: o Active substance: Ciprofloxacin 0.3%
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ophthalmologically and clinically healthy
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| ID | Title | Description |
|---|---|---|
| BG000 | PRO-174 | Active ingredient: Levofloxacin 0.5% o Dosage: 1 drop in both eyes, 8 times a day during the waking period PRO-174: Pharmaceutical form: ophthalmic solution
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number 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. | the analysis of the population was by protocol | Posted | Number | adverse events | during the 12 days of evaluation, including the safety call (day 12). |
|
the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRO-174 | Active ingredient: Levofloxacin 0.5% o Dosage: 1 drop in both eyes, 8 times a day during the waking period PRO-174: Pharmaceutical form: ophthalmic solution
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ocular burning | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Alonso Llamas Velázquez (clinical safety pharmacologist) | Laboratorios Sophia | +52 (33) 3001 4200 | 1259 | ricardo.llamas@sophia.com.mx |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2017 | Jul 23, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003234 | Conjunctivitis, Bacterial |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
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Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
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The blinding will correspond to the research subject and the principal investigator. In addition, the statistical analysis will be carried out in a blinded manner for the partial and final analysis.
The masking will be done using boxes in the primary packaging identical in the two groups. Blinding for the research subject and the researcher will be done by replacing the commercial labels in the case of the comparator in the bottles and the use of identical labels that contain the allocation number.
Blinding may be opened in the following cases:
|
| SophixÃn Ofteno® | Drug |
|
|
|
| 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. |
| will be evaluated at the end of the treatment at the final visit (day 7) |
| Number of Eyes With Epithelial Defects (ED) by Grade | 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. | will be evaluated at the end of the treatment at the final visit (day 7) |
| Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade | 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. | will be evaluated at the end of the treatment at the final visit (day 7) |
| Number of Eyes With Foreign Body Sensation (FBS) by Grade | Foreign body sensation 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. | will be evaluated at the end of the treatment at the final visit (day 7) |
| Number of Eyes With Ocular Pruritus (P) by Grade | Ocular pruritus 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. | will be evaluated at the end of the treatment at the final visit (day 7) |
| Number of Eyes of Chemosis | 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. | will be evaluated at the end of the treatment at the final visit (day 7) |
| 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 and higher scores indicate worse visual acuity. Snellen Scale: 20/200, 20/100, 20/70, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10 only the denominator of the fraction of each case is reported and averaged per group. | will be evaluated at the end of the treatment at the final visit (day 7) |
| BG001 |
| SophixÃn Ofteno® |
o Dosage: 1 drop in both eyes, 8 times a day during the waking period SophixÃn Ofteno®: o Active substance: Ciprofloxacin 0.3%
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
o Dosage: 1 drop in both eyes, 8 times a day during the waking period SophixÃn Ofteno®: o Active substance: Ciprofloxacin 0.3%
|
|
|
|
| Primary | 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. | the analysis of the study population was by protocol | Posted | Number | percentage of participants | will be evaluated at the end of the treatment at the final visit (day 7) | eyes | eyes |
|
|
|
|
| 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 study population was analyzed by protocol | Posted | Mean | Standard Deviation | mmHg | will be evaluated at the end of the treatment at the final visit (day 7) | eyes | eyes |
|
|
|
|
| Secondary | 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. | The study population was analyzed by protocol | Posted | Mean | Standard Deviation | seconds | will be evaluated at the end of the treatment at the final visit (day 7) | eyes | eyes |
|
|
|
|
| Secondary | Number of Eyes With Epithelial Defects (ED) by Grade | 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 study population was analyzed by protocol | Posted | Number | eyes | will be evaluated at the end of the treatment at the final visit (day 7) | eyes | eyes |
|
|
|
|
| Secondary | Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade | 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. | The study population was analyzed by protocol | Posted | Number | percentage of eyes | will be evaluated at the end of the treatment at the final visit (day 7) | eyes | eyes |
|
|
|
|
| Secondary | Number of Eyes With Foreign Body Sensation (FBS) by Grade | Foreign body sensation 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. | The study population was analyzed by protocol | Posted | Number | eyes | will be evaluated at the end of the treatment at the final visit (day 7) | eyes | eyes |
|
|
|
| Secondary | Number of Eyes With Ocular Pruritus (P) by Grade | Ocular pruritus 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. | The study population was analyzed by protocol grade 1 | Posted | Number | number of eyes with Ocular pruritus | will be evaluated at the end of the treatment at the final visit (day 7) | eyes | eyes |
|
|
|
|
| Secondary | Number of Eyes of Chemosis | 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 of the sample was performed by protocol | Posted | Number | eyes | will be evaluated at the end of the treatment at the final visit (day 7) | eyes | eyes |
|
|
|
| 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 and higher scores indicate worse visual acuity. Snellen Scale: 20/200, 20/100, 20/70, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10 only the denominator of the fraction of each case is reported and averaged per group. | Posted | Mean | Standard Deviation | units on a scale (snellen) | will be evaluated at the end of the treatment at the final visit (day 7) | eyes | eyes |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 9 |
| 15 |
| EG001 | SophixÃn Ofteno® | o Dosage: 1 drop in both eyes, 8 times a day during the waking period SophixÃn Ofteno®: o Active substance: Ciprofloxacin 0.3%
| 0 | 15 | 0 | 15 | 8 | 15 |
| itching in the eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| conjunctival hyperemia | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| tearing | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| skin rash | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
only the sponsor has the decision to disseminate or publish the information obtained from the investigation and the PIs involved must submit a formal request to the sponsor if they are willing to disseminate or publish such information, they may only publish them if they have the written authorization of the sponsor (Laboratoios Sophia S.A. de C.V.).
| D001423 |
| Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015817 | Eye Infections |
| mild |
|
| luorescein grade 1 |
|
| fluorescein grade 0 |
|
| Chi-squared, Corrected |
| 0.238 |
statistical analysis between groups for final visit with fluorescein |
| Non-Inferiority |
it is considered as noninferiority if there is no difference greater than twenty percent between both medications |
| Mild |
|
| moderate |
|
| severo |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|