Dry Eye
Conditions
Keywords
Dry eye, eye lubricant, sodium hyaluronate
Brief summary
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
Interventions
DRUGlagricel ofteno multidose
* Dosage: 1 drop 4 times a day per 7 days, both eyes * Route of administration: Ophthalmic
DRUGlagricel ofteno single dose
* Dosage: 1 drop 4 times a day per 7 days, both eyes * Route of administration: Ophthalmic
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single-center, controlled, parallel group, open, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* To be clinically healthy * To have the ability to voluntarily grant your signed informed consent * To have the willingness to comply with scheduled visits treatment plan and other study procedures * Women in reproductive age should ensure the continuation (initiated ≥ 30 days prior to the signing of the informed consent) to use a hormonal contraceptive method or intrauterine device during the study period. * To have a better corrected visual acuity of 20/30 or better in both eyes. * To have vital signs in normal parameters. * To have an intraocular pressure between ≥10 and ≤ 21 mmHg.
Exclusion criteria
* To be user of ophthalmic topical products of any kind. * To be user of medicines, or herbal products, by any other route of administration. * In the case of women: being pregnant, breastfeeding or planning to get pregnant in the study period. * Having participated in clinical research studies 90 days prior to inclusion in this study. * Having previously participated in this same study. * To be a user of contact lenses and can not suspend their use during the study. * Having initiated the use of hormonal contraceptives or intrauterine devices, 30 days prior to inclusion in the present study. * To have a history of any chronic degenerative disease. * Having inflammatory or infectious disease, active at the time of admission to the study. * Having injuries or unresolved injuries at the time of admission to the study. * Having a history of any type of eye surgery. * Having undergone surgical procedures, not ophthalmological, in the last 3 months. * To be or to have an immediate family member (for example: spouse, parent / legal guardian, brother or child) who is part of the research site staff or the sponsor who participates directly in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Adverse Events (AEs) | during the 10 days of evaluation, including the safety call (day 11). | the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent |
| Eye Comfort Index (ECI) | will be evaluated at the end of the treatment (day 8, final visit) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epithelial Defects (ED) Green Lissamine | will be evaluated at the end of the treatment (day 8, final visit) | 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. |
| Visual Acuity (VA) | will be evaluated at the end of the treatment (day 8, final visit) | 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. |
| Chemosis | will be evaluated at the end of the treatment (day 8, final visit) | 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 |
| Conjunctival Hyperemia (CH) | will be evaluated at the end of the treatment (day 8, final visit) | 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. |
| Epithelial Defects (ED) Fluorescein Stain | will be evaluated at the end of the treatment (day 8, final visit) | 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. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| 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 | 18 |
| Total | 34 |
Baseline characteristics
| Characteristic | Lagricel® Ofteno Single Dose | Total | Lagricel® Ofteno Multidose |
|---|---|---|---|
| Age, Continuous | 29.7 years STANDARD_DEVIATION 7.9 | 29.0 years STANDARD_DEVIATION 7.33 | 27.8 years STANDARD_DEVIATION 6.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Mexico | 18 participants | 34 participants | 16 participants |
| Sex: Female, Male Female | 9 Participants | 21 Participants | 12 Participants |
| Sex: Female, Male Male | 9 Participants | 13 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 18 |
| other Total, other adverse events | 7 / 16 | 8 / 18 |
| serious Total, serious adverse events | 0 / 16 | 0 / 18 |
Outcome results
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).
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Lagricel® Ofteno Multidose | Eye Comfort Index (ECI) | Inicial ECI | 29.98 score on a scale |
| Lagricel® Ofteno Multidose | Eye Comfort Index (ECI) | Final ECI | 18.76 score on a scale |
| Lagricel® Ofteno Single Dose | Eye Comfort Index (ECI) | Inicial ECI | 27.28 score on a scale |
| Lagricel® Ofteno Single Dose | Eye Comfort Index (ECI) | Final ECI | 18.01 score on a scale |
p-value: 0.442Wilcoxon (Mann-Whitney)
Comparison: Final vs initial Eye Comfort Indexp-value: 0.009Wilcoxon (Mann-Whitney)
Comparison: Final vs initial Eye Comfort Indexp-value: 0.002Wilcoxon (Mann-Whitney)
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
Time frame: during the 10 days of evaluation, including the safety call (day 11).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lagricel® Ofteno Multidose | Presence of Adverse Events (AEs) | 7 Participants |
| Lagricel® Ofteno Single Dose | Presence of Adverse Events (AEs) | 8 Participants |
p-value: 0.409Wilcoxon (Mann-Whitney)
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
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
Population: Initial Chemosis (Lagricel® Ofteno Multidose, n=0; Lagricel® Ofteno Single dose, n=0)
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Lagricel® Ofteno Multidose | Chemosis | Final chemosis present | 0 Eyes |
| Lagricel® Ofteno Multidose | Chemosis | Final chemosis absent | 32 Eyes |
| Lagricel® Ofteno Single Dose | Chemosis | Final chemosis present | 0 Eyes |
| Lagricel® Ofteno Single Dose | Chemosis | Final chemosis absent | 36 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.
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
Population: Initial conjunctival hyperemia (Lagricel® Ofteno Multidose n=26; Lagricel® Ofteno Single dose n=28)
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Lagricel® Ofteno Multidose | Conjunctival Hyperemia (CH) | Hyperemia grade 0 (Normal) | 32 Eyes |
| Lagricel® Ofteno Multidose | Conjunctival Hyperemia (CH) | Hyperemia grade 1 (Very Light) | 0 Eyes |
| Lagricel® Ofteno Multidose | Conjunctival Hyperemia (CH) | Hyperemia grade 2 (Light) | 0 Eyes |
| Lagricel® Ofteno Multidose | Conjunctival Hyperemia (CH) | Hyperemia grade 3 (Mild) | 0 Eyes |
| Lagricel® Ofteno Multidose | Conjunctival Hyperemia (CH) | Hyperemia grade 4 (Moderate) | 0 Eyes |
| Lagricel® Ofteno Multidose | Conjunctival Hyperemia (CH) | Hyperemia grade 5 (Severe) | 0 Eyes |
| Lagricel® Ofteno Single Dose | Conjunctival Hyperemia (CH) | Hyperemia grade 4 (Moderate) | 0 Eyes |
| Lagricel® Ofteno Single Dose | Conjunctival Hyperemia (CH) | Hyperemia grade 0 (Normal) | 36 Eyes |
| Lagricel® Ofteno Single Dose | Conjunctival Hyperemia (CH) | Hyperemia grade 3 (Mild) | 0 Eyes |
| Lagricel® Ofteno Single Dose | Conjunctival Hyperemia (CH) | Hyperemia grade 1 (Very Light) | 0 Eyes |
| Lagricel® Ofteno Single Dose | Conjunctival Hyperemia (CH) | Hyperemia grade 5 (Severe) | 0 Eyes |
| Lagricel® Ofteno Single Dose | Conjunctival Hyperemia (CH) | Hyperemia grade 2 (Light) | 0 Eyes |
p-value: 1Chi-squared, Corrected
Comparison: Final vs initial conjunctival hyperemiap-value: 0.031Fisher Exact
Comparison: Final vs initial conjunctival hyperemiap-value: 1Chi-squared, Corrected
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.
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
Population: 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)
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Lagricel® Ofteno Multidose | Epithelial Defects (ED) Fluorescein Stain | Final Fluorescein Staining Grade 0 | 30 Eyes |
| Lagricel® Ofteno Multidose | Epithelial Defects (ED) Fluorescein Stain | Final Fluorescein Staining Grade 1 | 2 Eyes |
| Lagricel® Ofteno Single Dose | Epithelial Defects (ED) Fluorescein Stain | Final Fluorescein Staining Grade 0 | 34 Eyes |
| Lagricel® Ofteno Single Dose | Epithelial Defects (ED) Fluorescein Stain | Final Fluorescein Staining Grade 1 | 2 Eyes |
p-value: 1Fisher Exact
Comparison: Final vs initial fluorescein stainingp-value: 0.041Chi-squared
p-value: 0.665Chi-squared
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.
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
Population: 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)
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Lagricel® Ofteno Multidose | Epithelial Defects (ED) Green Lissamine | Final Lissamine Green Staining Grade 0 | 29 Eyes |
| Lagricel® Ofteno Multidose | Epithelial Defects (ED) Green Lissamine | Final Lissamine Green Staining Grade 1 | 3 Eyes |
| Lagricel® Ofteno Single Dose | Epithelial Defects (ED) Green Lissamine | Final Lissamine Green Staining Grade 0 | 31 Eyes |
| Lagricel® Ofteno Single Dose | Epithelial Defects (ED) Green Lissamine | Final Lissamine Green Staining Grade 1 | 5 Eyes |
p-value: 0.713Fisher Exact
Comparison: Final vs initial lissamine green stainingp-value: 0.002Chi-squared
Comparison: Final vs initial lissamine green stainingp-value: 0.777Chi-squared
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.
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lagricel® Ofteno Multidose | Visual Acuity (VA) | Final VA | 0.988 LogMAR | Standard Deviation 0.05 |
| Lagricel® Ofteno Multidose | Visual Acuity (VA) | Initial VA | 0.969 LogMAR | Standard Deviation 0.09 |
| Lagricel® Ofteno Single Dose | Visual Acuity (VA) | Final VA | 0.989 LogMAR | Standard Deviation 0.05 |
| Lagricel® Ofteno Single Dose | Visual Acuity (VA) | Initial VA | 0.989 LogMAR | Standard Deviation 0.05 |
p-value: 0.904Wilcoxon (Mann-Whitney)
Comparison: Final vs initial VAp-value: 0.157Sign test
Comparison: Final vs initial VAp-value: 1Sign test