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Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Study period:
3 to 4 months
treatment duration: 10 days
Number of patients:
30 subjects, divided into 3 groups,10 subjects (20 eyes) exposed by group.
Diagnosis and main inclusion criteria:
Test product, dose and route of administration:
- PRO-087. Chondroitin sulfate 0.18% / 0.1% sodium hyaluronate, ophthalmic solution preservative free. made by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
Reference product, dose and route of administration:
Xyel Ofteno®. Xanthan gum 0.09% / Chondroitin sulfate 0.1% / preservative-free ophthalmic solution. made by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
Systane Ultra®. Polyethylene glycol 400 0.4%, propylene glycol 0.3%. made by Alcon Laboratories, Inc.
Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
Evaluation criteria:
Primary security outcome variables:
Secondary outcome variables:
Primary outcome variables of tolerability:
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 Kruskal-Wallis test for quantitative variables. The difference between the qualitative variables will be analyzed by means of chi square (Chi2). An alpha ≤ 0.05 will be considered significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-087 | Experimental | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. |
|
| Xyel Ofteno | Active Comparator | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. |
|
| Systane ultra | Active Comparator | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-087 | Drug | The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13. |
|
| 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 10) |
| 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 13 days of evaluation, including the safety call (day 13). |
| Intraocular Pressure (IOP) |
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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 |
|---|---|---|---|---|---|---|
| Private Ophthalmological Office | Zapopan | Jalisco | 45050 | 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-087 | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13. |
| FG001 | Xyel Ofteno | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13. |
| FG002 | Systane Ultra | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc. Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Clinical and ophthalmologically healthy subjects who met the inclusion criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | PRO-087 | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13. |
| 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/mm2 | will be evaluated at the end of the treatment at the final visit (day 10) | eyes | eyes |
|
The monitoring of the adverse events was made throughout the 10 days of intervention of the product and 3 days later by means of a safety telephone call, totaling 13 days of pharmacovigilance.
the treatment is a topical drug, the subjects of investigation with this intervention are not in danger of death.
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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-087 | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. PRO-087: The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | 20.1 | 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 | Jun 29, 2016 | May 9, 2019 | 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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| ID | Term |
|---|---|
| C501944 | chondroitin sulfate, sodium hyaluronate drug combination |
| C000595213 | polyethylene glycol 400 |
| C002563 | xanthan gum |
| D002809 | Chondroitin Sulfates |
| ID | Term |
|---|---|
| D002807 | Chondroitin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
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Blinding It will consist in the elimination of the primary label (commercial) in the case of Xyel Ofteno® and Systane Ultra® and the placement of a label identical to the other interventions. Because the bottle in which Systane Ultra® is packaged differs in the color and shape of the lid used by Xyel Ofteno® and PRO-087, a masking will be carried out on the primary packaging which will be identical for the three interventions.The allocation sequence will be generated by personnel assigned. The research center will receive a set of envelopes which will contain the intervention number individually. The envelopes will be identical on the outside. Each of these envelopes will be shown to the participants for their election by the principal investigator or by a designated member of their team.
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 all analysis.
|
| Systane Ultra | Drug | The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13. |
|
|
| Xyel Ofteno | Drug | The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13. |
|
|
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 10) |
| Epithelial Defects (ED) | 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 10) |
| 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 10) |
| Conjunctival Hyperemia (CH) | Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very mild / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Moderate and severe are considered pathological. | will be evaluated at the end of the treatment at the final visit (day 10) |
| 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 10) |
| 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 10) |
| 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 10) |
| 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 10) |
| BG001 | Xyel Ofteno | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13. |
| BG002 | Systane Ultra | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc. Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Intra Ocular Pressure (IOP) | Mean | Standard Deviation | mmHg |
|
| tear film breakup (BUT) | Mean | Standard Deviation | seconds |
|
| goblet cells | Mean | Standard Deviation | cells /mm2 |
|
| Xyel Ofteno |
Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13. |
| OG002 | Systane Ultra | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc. Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13. |
|
|
|
| Secondary | 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 | Number | adverse events | during the 13 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 | Posted | Mean | Standard Deviation | mmHg | will be evaluated at the end of the treatment at the final visit (day 10) |
|
|
|
| Secondary | Epithelial Defects (ED) | 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. | Posted | Number | eyes | will be evaluated at the end of the treatment at the final visit (day 10) | 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. | Posted | Mean | Standard Deviation | seconds | will be evaluated at the end of the treatment at the final visit (day 10) | 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 mild / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Moderate and severe are considered pathological. | Posted | Number | cases | will be evaluated at the end of the treatment at the final visit (day 10) | 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. | Posted | Number | cases | will be evaluated at the end of the treatment at the final visit (day 10) | 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. | Posted | Number | cases | will be evaluated at the end of the treatment at the final visit (day 10) | 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. | Posted | Number | cases | will be evaluated at the end of the treatment at the final visit (day 10) | 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. | Posted | Number | cases | will be evaluated at the end of the treatment at the final visit (day 10) | eyes | eyes |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 5 |
| 10 |
| EG001 | Xyel Ofteno | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. Xyel Ofteno: The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13. | 0 | 10 | 0 | 10 | 4 | 10 |
| EG002 | Systane Ultra | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc. Systane Ultra: The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13. | 0 | 10 | 0 | 10 | 5 | 10 |
| hypertransaminasemia | Blood and lymphatic system disorders | 20.1 | Non-systematic Assessment |
|
| ocular burning | Eye disorders | 20.1 | Non-systematic Assessment |
|
| ocular itching | Eye disorders | 20.1 | Non-systematic Assessment |
|
| ocular discharge | Eye disorders | 20.1 | Non-systematic Assessment |
|
| ocular foreign body sensation | Eye disorders | 20.1 | Non-systematic Assessment |
|
| dry eye | Eye disorders | 20.1 | Non-systematic Assessment |
|
| skin rash | Skin and subcutaneous tissue disorders | 20.1 | Non-systematic Assessment |
|
| hyperglycemia | Blood and lymphatic system disorders | 20.1 | Non-systematic Assessment |
|
only the sponsor can publish the information held by the research centers, if the principal investigator of a center wishes to publish the information, it must have the written consent of the sponsor.
| Title | Measurements |
|---|---|
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| grade II |
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| Title | Measurements |
|---|---|
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| Mild |
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Mild |
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Mild |
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| Moderate |
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| Severe |
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