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Phase I clinical study, to evaluate the safety and tolerability of the ophthalmic solution PRO-179 compared with Travatan®, on the ocular surface of clinically healthy subjects.
Goals: To evaluate the safety and tolerability of the formulation PRO-179 manufactured by Sophia Laboratories S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:The ophthalmic solution PRO-179 presents a profile of safety and tolerability similar to Travatan® in healthy subjects.
Methodology: Clinical trial Phase I, controlled, of parallel groups, double blind, with randomization.
Number of patients: n= 24, 12 subjects per group (both eyes). Main inclusion criteria: Clinically healthy subjects.
duration: 10 days.
Duration of subject in the study: 15 to 22 days.
Adverse events will be reported and cataloged based on the MedDRA dictionary and will be reported to the corresponding regulatory entity.
The sponsor will carry out monitoring or quality visits to the research sites where it corroborates the information of the source documents and will contrast them with the information presented in the electronic CRF. Electronic case report forms will be evaluated by the clinical research associate and the clinical team of the sponsor (medical ophthalmologist researcher and pharmacologist of clinical safety).
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 by means of the Mann-Whitney U test for the quantitative variables for the difference between the groups. The difference between the qualitative variables will be analyzed by means of X2 (Chi2) or Fisher's exact. An alpha ≤ 0.05 will be considered significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-179 | Experimental | Dosage: 1 drop every 24 hours, at night, in both eyes. |
|
| Travatan® | Active Comparator | Dosage: 1 drop every 24 hours, at night, in both eyes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO 179 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 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. it will be evaluated by the number of reported cases per group. | during the 14 days of evaluation, including the safety call (day 14). |
| Eye Comfort Index | It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.(0: None discomfort, 100: high discomfort). | will be evaluated at the end of the treatment, at the final visit (day 11) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With Epithelial Defects by Grade | The epithelial defects will be evaluated by means of two stains, lissamine green 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Intraocular Pressure | 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) |
Inclusion Criteria:
Blood count (BH): Hemoglobin, erythrocytes, hematocrit, total leukocytes, platelets, mean corpuscular volume and mean corpuscular hemoglobin.
Blood chemistry of three elements (QS): Glucose, urea and creatinine.
Liver function tests (PFH): Aspartate Aminotransferase and Alanine Aminotransferase, total bilirubin, direct and indirect.
Exclusion 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 |
|---|---|---|---|---|---|---|
| Jose Navarro Partida | Guadalajara | Jalisco | 45160 | 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-179 | Dosage: 1 drop every 24 hours, at night, in both eyes. PRO 179: o Generic name: Travoprost
|
| FG001 | Travatan® | Dosage: 1 drop every 24 hours, at night, in both eyes. Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PRO-179 | Dosage: 1 drop every 24 hours, at night, in both eyes. PRO 179: o Generic name: Travoprost
|
| 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 Participants With Adverse Events | 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. it will be evaluated by the number of reported cases per group. | the analysis was carried out by intention to treat (ITT) | Posted | Count of Participants | Participants | during the 14 days of evaluation, including the safety call (day 14). |
|
Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
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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-179 | Dosage: 1 drop every 24 hours, at night, in both eyes. PRO 179: o Generic name: Travoprost
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ocular hypotony | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ocular burning | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PhD. Ricardo Llamas | 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 | Aug 1, 2018 | May 23, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Not provided
| ID | Term |
|---|---|
| D000069557 | Travoprost |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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double blind, with randomization.
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Blinding will correspond to the principal investigator and coinvestigator. In addition, the statistical analysis will be carried out in a blinded manner for the final analysis. Blinding can not be guaranteed in the subject.
The masking will be done through the secondary container. The primary packaging will not be masked by the morphological difference between them. The sponsor and the research center will have two teams blinded / not blinded.
They will be identified by means of identical labels. Which, in accordance with current and applicable regulations, must contain at least:
|
|
| Travatan 0.004 % Ophthalmic Solution | Drug |
|
|
|
| will be evaluated at the end of the treatment, at the final visit (day 11) |
| Visual Ability | 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 the worst vision is 20/200, higher values represent a worst vision. The result of the Snellen chart has equivalents in an international logarithmic system called Logmar (logarithm of the minimum angle of resolution) for better understanding. Snellen Scale: 20/200, 20/100, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10. Snellen / LogMAR equivalences: 20/200= 1.0, 20/100=0.7, 20/50=0.4, 20/40=0.3, 20/30=0.2, 20/25=0.1, 20/20=0.0, 20/15=0.13, 20/12=0.2, 20/10=-0.3, etc. | will be evaluated at the end of the treatment, at the final visit (day 11) |
| 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 11) |
| 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 11) |
| BG001 | Travatan® | Dosage: 1 drop every 24 hours, at night, in both eyes. Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Travatan® | Dosage: 1 drop every 24 hours, at night, in both eyes. Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
|
|
|
|
| Primary | Eye Comfort Index | It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.(0: None discomfort, 100: high discomfort). | the analysis was per protocol | Posted | Mean | Standard Deviation | score on a scale | will be evaluated at the end of the treatment, at the final visit (day 11) |
|
|
|
| Secondary | Number of Eyes With Epithelial Defects by Grade | The epithelial defects will be evaluated by means of two stains, lissamine green 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 analysis was per protocol | Posted | Count of Units | eyes | will be evaluated at the end of the treatment, at the final visit (day 11) | eyes | eyes |
|
|
|
|
| Secondary | Visual Ability | 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 the worst vision is 20/200, higher values represent a worst vision. The result of the Snellen chart has equivalents in an international logarithmic system called Logmar (logarithm of the minimum angle of resolution) for better understanding. Snellen Scale: 20/200, 20/100, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10. Snellen / LogMAR equivalences: 20/200= 1.0, 20/100=0.7, 20/50=0.4, 20/40=0.3, 20/30=0.2, 20/25=0.1, 20/20=0.0, 20/15=0.13, 20/12=0.2, 20/10=-0.3, etc. | the analysis was per protocol | Posted | Mean | Standard Deviation | LogMAR | will be evaluated at the end of the treatment, at the final visit (day 11) |
|
|
|
|
| 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 analysis was per protocol | Posted | Count of Units | eyes | will be evaluated at the end of the treatment, at the final visit (day 11) | 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 analysis was per protocol | Posted | Count of Units | eyes | will be evaluated at the end of the treatment, at the final visit (day 11) | eyes | eyes |
|
|
|
| Other Pre-specified | Changes in Intraocular Pressure | 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 analysis was per protocol | Posted | Mean | Standard Deviation | mmHg | will be evaluated at the end of the treatment, at the final visit (day 11) | eyes | eyes |
|
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 10 |
| 12 |
| EG001 | Travatan® | Dosage: 1 drop every 24 hours, at night, in both eyes. Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
| 0 | 12 | 0 | 12 | 11 | 12 |
| headache | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| eye pain | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| eyelid pain | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| photophobia | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| ocular hypotony | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| eyelid swelling | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| tearing | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| red eye | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| eye itching | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| foreign body sensation | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Dry eye | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
The Principal Investigator undertakes not to publish or communicate data collected from the study, unless there is prior written agreement of Laboratorios Sophia, S.A. from C.V.
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| Green lissamine grade 2 |
|
| Green lissamine grade 3 |
|
| Green lissamine grade 4 |
|
| Fluorescein grade 0 |
|
| Fluorescein grade 1 |
|
| Fluorescein grade 2 |
|
| Fluorescein grade 3 |
|
| Fluorescein grade 4 |
|
| 0.667 |
| Other |
| Mild (2) |
|
| Moderate (3) |
|
| Severe (4) |
|