Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Title of the study:
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic gel PRO-167 versus Corneregel®, on the ocular surface of ophthalmological and clinically healthy subjects.
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Goals:
To evaluate the safety and tolerability of the ophthalmic gel PRO-167 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
Ophthalmic gel PRO-167 has a safety and tolerability profile similar to that of its comparator in healthy subjects.
Therapeutic indication:
Corneal surface reepithelizing
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 quantitative variables. The difference between the qualitative variables will be analyzed by means of square chi (Chi2). An alpha ≤ 0.05 will be considered significant.
Study period:
3 to 4 months
Development phase: I
Number of patients:
24 subjects, divided into 2 groups (12 eyes exposed per group)
Test product, dose and route of administration, lot number:
PRO-167. Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico.
Reference product, dose and route of administration, lot:
Evaluation criteria:
Primary security outcome variable:
- Density of goblet cells.
Secondary security variables:
Secondary outcome variables:
Outcome variables of tolerability:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-167 | Experimental | Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom |
|
| Corneregel® | Active Comparator | Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-167 | Drug | Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico. Route of administration: ophthalmic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Goblet Cell Density (GCD) | the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter | will be evaluated at the end of the treatment at the final visit (day 11) |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Adverse Events (EAS) | the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. | during the 11 days of evaluation, including the safety call (day 13). |
| Intraocular Pressure (IOP) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leopoldo Baiza Durán, MD | Laboratorios Sophia S.A de C.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Oftalmológico San Angel | Guadalajara | Jalisco | 44200 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PRO-167 | Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico. Route of administration: ophthalmic |
| FG001 | Corneregel® | Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac. Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany. Route of administration: ophthalmic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
clinically and ophthalmologically healthy subjects
| ID | Title | Description |
|---|---|---|
| BG000 | PRO-167 | Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico. Route of administration: ophthalmic |
| BG001 | Corneregel® |
| 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 | Goblet Cell Density (GCD) | the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter | Posted | Mean | Standard Deviation | cells/mm^2 | will be evaluated at the end of the treatment at the final visit (day 11) | eyes | eyes |
|
Adverse events were monitored for a total of 13 days, including the scrutiny visit (day 0) until the safety call (day 13)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRO-167 | Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom PRO-167: Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico. Route of administration: ophthalmic |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Alonso Llamas Velázquez (clinical safety pharmacologist) | Laboratorios Sophia | +52 (33) 3001 4200 | 1259 | ricardo.llamas@sophia.com.mx |
Not provided
| 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 | Aug 8, 2016 | Sep 11, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C007288 | dexpanthenol |
Not provided
Not provided
Not provided
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Not provided
Not provided
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:
|
| Corneregel | Drug | Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany. Route of administration: ophthalmic |
|
|
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 11) |
| 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 greater than 10 seconds. | will be evaluated at the end of the treatment at the final visit (day 11) |
| 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 11) |
| Ocular Burning (OB) | 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. | will be evaluated at the end of the treatment at the final visit (day 11) |
| Epithelial Defects (ED) | The epithelial defects will be evaluated by means of two stains, green lissamine, 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 11) |
| 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. | will be evaluated at the end of the treatment at the final visit (day 11) |
| Foreign Body Sensation (FBS) | 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. 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. | will be evaluated at the end of the treatment at the final visit (day 11) |
| Ocular Pruritus (P) | 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. 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. | will be evaluated at the end of the treatment at the final visit (day 11) |
Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac. Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany. Route of administration: ophthalmic |
| BG002 | Total | Total of all reporting groups |
| eyes |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
|
|
|
| Secondary | Presence of Adverse Events (EAS) | the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. | Posted | Number | cases | during the 11 days of evaluation, including the safety call (day 13). |
|
|
|
|
| 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 of the sample was carried out by protocol | Posted | Mean | Standard Deviation | mmHg | will be evaluated at the end of the treatment at the final visit (day 11) | 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 greater than 10 seconds. | the statistical analysis of the sample was carried out by protocol | Posted | Mean | Standard Deviation | seconds | will be evaluated at the end of the treatment at the final visit (day 11) | eyes | eyes |
|
|
|
|
| Secondary | 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 carried out by protocol | Posted | Number | cases | will be evaluated at the end of the treatment at the final visit (day 11) | eyes | eyes |
|
|
|
| Secondary | Ocular Burning (OB) | 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 of the sample was carried out by protocol | Posted | Number | percentage of participants | will be evaluated at the end of the treatment at the final visit (day 11) | eyes | eyes |
|
|
|
|
| Secondary | Epithelial Defects (ED) | The epithelial defects will be evaluated by means of two stains, green lissamine, 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 of the sample was carried out by protocol | Posted | Number | cases | will be evaluated at the end of the treatment at the final visit (day 11) | eyes | eyes |
|
|
|
|
| Secondary | 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. | the statistical analysis of the sample was carried out by protocol | Posted | Number | percentage of participants | will be evaluated at the end of the treatment at the final visit (day 11) | eyes | eyes |
|
|
|
|
| Secondary | Foreign Body Sensation (FBS) | 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. 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 of the sample was carried out by protocol | Posted | Number | percentage of participants | will be evaluated at the end of the treatment at the final visit (day 11) | eyes | eyes |
|
|
|
|
| Secondary | Ocular Pruritus (P) | 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. 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 of the sample was carried out by protocol | Posted | Number | percentage of participants | will be evaluated at the end of the treatment at the final visit (day 11) | eyes | eyes |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 7 |
| 12 |
| EG001 | Corneregel® | Dose: a strip approximately 1 cm long, 4 times a day during the period of vigil, in the bottom of the right eye sac. Corneregel: Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany. Route of administration: ophthalmic | 0 | 12 | 0 | 12 | 6 | 12 |
| rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| earache | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| dysgeusia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| non-infectious diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Food Allergy | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| eyelid bruise | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ocular burning | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| elevated liver enzymes | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Researchers can not disseminate research results unless they obtain written authorization from the sponsor.
| moderate |
|
| Severe |
|
| grade II |
|
| Mild |
|
| Mild |
|
| Moderate |
|
| Mild |
|
| Moderate |
|