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Study design: Phase I clinical trial, single-center, controlled, parallel group, open, randomized.
Number of subjects: n = 34 evaluable subjects, 17 evaluable subjects per group (both eyes).
Estimated duration of the study: 5 months
Therapeutic indication: Eye lubricant Use: Dry Eye
Objective:To evaluate the safety and tolerability of Lagricel® Ofteno multidose manufactured by Laboratorios Sophia on the ocular surface of clinically healthy subjects.
Hypothesis:
H0 = Lagricel® Ofteno multidose ophthalmic solution has a safety and tolerability profile similar to Lagricel® Ofteno single dose in healthy subjects.
H1 = Lagricel® Ofteno multidose ophthalmic solution has a different safety and tolerability profile than Lagricel® Ofteno single dose in healthy subjects.
Main inclusion criteria: Clinically healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lagricel® Ofteno Multidose | Experimental | Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia |
|
| Lagricel® Ofteno Single dose | Active Comparator | Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lagricel ofteno multidose | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Adverse Events (AEs) | the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent | during the 10 days of evaluation, including the safety call (day 11). |
| Eye Comfort Index (ECI) | 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 (day 8, final visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (VA) | Visual acuity (VA) is a test of visual function. It will be evaluated at baseline, without refractive correction with the Snellen chart.Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3meters from the subject to be evaluated. The snellen chart consists of a booklet with 11 lines composed of letters, each line has a different size and a different weighting. the subject is placed at a safe distance and the contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20. |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Biomedical research G & LS de RL de CV | Guadalajara | Jalisco | 45070 | 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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Laboratorios Sophia, S.A. de C.V., serving as the sponsor of the study, assumes full responsibility for its function and retains exclusive ownership rights over the results of the study.
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. de C.V.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lagricel® Ofteno Multidose | Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes - Route of administration: Ophthalmic |
| FG001 | Lagricel® Ofteno Single Dose | Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes - Route of administration: Ophthalmic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lagricel® Ofteno Multidose | Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes - Route of administration: Ophthalmic |
| BG001 | Lagricel® Ofteno Single Dose |
| 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 | Presence of Adverse Events (AEs) | the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent | Posted | Count of Participants | Participants | during the 10 days of evaluation, including the safety call (day 11). |
|
Adverse events were monitored throughout the study, which lasted about 1 month and 15 days.
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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 | Lagricel® Ofteno Multidose | Lagricel® Ofteno Multidose 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia lagricel ofteno multidose: - Dosage: 1 drop 4 times a day per 7 days, both eyes - Route of administration: Ophthalmic |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| blurred vision | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alejandra Sanchez-Rios | Laboratorios Sophia | +52 (33) 3001 4200 | 1190 | alejandra.sanchez@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 | Jan 31, 2019 | Mar 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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single-center, controlled, parallel group, open, randomized
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| lagricel ofteno single dose | Drug |
|
|
|
| will be evaluated at the end of the treatment (day 8, final visit) |
| 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. | will be evaluated at the end of the treatment (day 8, final visit) |
| 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. | will be evaluated at the end of the treatment (day 8, final visit) |
| Conjunctival Hyperemia (CH) | Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as 0.-Normal / 1.-Very Light/ 2.- Light/ 3.-Mild / 4.-Moderate / 5.- 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 (day 8, final visit) |
| Chemosis | It is defined as conjunctival edema, the result of an inflammatory reaction. It is qualified as present or absent. The evaluator will use a narrow beam of light at 60 ° and will measure if the conjunctiva separates from the sclera by ≥ 1/3 of the total eyelid opening | will be evaluated at the end of the treatment (day 8, final visit) |
Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes - Route of administration: Ophthalmic |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Eye Comfort Index (ECI) | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | will be evaluated at the end of the treatment (day 8, final visit) |
|
|
|
|
| Secondary | Visual Acuity (VA) | Visual acuity (VA) is a test of visual function. It will be evaluated at baseline, without refractive correction with the Snellen chart.Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3meters from the subject to be evaluated. The snellen chart consists of a booklet with 11 lines composed of letters, each line has a different size and a different weighting. the subject is placed at a safe distance and the contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20. | Posted | Mean | Standard Deviation | LogMAR | will be evaluated at the end of the treatment (day 8, final visit) |
|
|
|
|
| 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. | Initial Fluorescein Staining Grade 0 (Lagricel® Ofteno Multidose n=22; Lagricel® Ofteno Single dose n=26) Initial Fluorescein Staining Grade 1 (Lagricel® Ofteno Multidose n=8; Lagricel® Ofteno Single dose n=8) Initial Fluorescein Staining Grade 2 (Lagricel® Ofteno Multidose n=2; Lagricel® Ofteno Single dose n=2) | Posted | Count of Units | Eyes | will be evaluated at the end of the treatment (day 8, final visit) | Eyes | Eyes |
|
|
|
|
| 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. | Initial Lissamine Green Staining Grade 0 (Lagricel® Ofteno Multidose n=24; Lagricel® Ofteno Single dose n= 23 Initial Lissamine Green Staining Grade 1 (Lagricel® Ofteno Multidose n=6; Lagricel® Ofteno Single dose n= 11 Initial Lissamine Green Staining Grade 2 (Lagricel® Ofteno Multidose n=1; Lagricel® Ofteno Single dose n= 2 Initial Lissamine Green Staining Grade 3 (Lagricel® Ofteno Multidose n=1; Lagricel® Ofteno Single dose n= 0) | Posted | Count of Units | Eyes | will be evaluated at the end of the treatment (day 8, final visit) | 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 0.-Normal / 1.-Very Light/ 2.- Light/ 3.-Mild / 4.-Moderate / 5.- Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological. | Initial conjunctival hyperemia (Lagricel® Ofteno Multidose n=26; Lagricel® Ofteno Single dose n=28) | Posted | Count of Units | Eyes | will be evaluated at the end of the treatment (day 8, final visit) | Eyes | Eyes |
|
|
|
|
| Secondary | Chemosis | It is defined as conjunctival edema, the result of an inflammatory reaction. It is qualified as present or absent. The evaluator will use a narrow beam of light at 60 ° and will measure if the conjunctiva separates from the sclera by ≥ 1/3 of the total eyelid opening | Initial Chemosis (Lagricel® Ofteno Multidose, n=0; Lagricel® Ofteno Single dose, n=0) | Posted | Count of Units | Eyes | will be evaluated at the end of the treatment (day 8, final visit) | Eyes | Eyes |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 7 |
| 16 |
| EG001 | Lagricel® Ofteno Single Dose | Lagricel® Ofteno single dose. 0.4% hyaluronate. Ophthalmic solution. Laboratorios Sophia lagricel ofteno single dose: - Dosage: 1 drop 4 times a day per 7 days, both eyes - Route of administration: Ophthalmic | 0 | 18 | 0 | 18 | 8 | 18 |
| burning eyes | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| eye itching | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| dysgeusia | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Tearing | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| foreign body sensation | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 22.0 | 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.).
| Wilcoxon (Mann-Whitney) |
| 0.009 |
| Equivalence |
F=2.606, 15.926 |
| Final vs initial Eye Comfort Index | Wilcoxon (Mann-Whitney) | 0.002 | Equivalence | F=3.051, 19.336 |
| Sign test |
| 0.157 |
| Equivalence |
F=-1.414, 1.061 |
| Final vs initial VA | Sign test | 1.000 | Equivalence |
| Chi-squared |
| 0.041 |
| Equivalence |
Chi-squared (2)= 6.400 |
| Chi-squared | 0.665 | Equivalence | Chi-squared (2)=0.814 |
| Chi-squared |
| 0.002 |
| Equivalence |
Chi-squared (3)=14.345 |
| Final vs initial lissamine green staining | Chi-squared | 0.777 | Equivalence | Chi-squared (2)=0.506 |
| Hyperemia grade 2 (Light) |
|
| Hyperemia grade 3 (Mild) |
|
| Hyperemia grade 4 (Moderate) |
|
| Hyperemia grade 5 (Severe) |
|
| Fisher Exact |
| 0.031 |
| Equivalence |
F=4.167, 1 |
| Final vs initial conjunctival hyperemia | Chi-squared, Corrected | 1.000 | Equivalence | No significant change was observed. |