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Clinical phase I, controlled, non comparative, open, single center study evaluating the safety and tolerability of ophthalmic solution PRO-172 when applied on the ocular surface of healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-172 | Experimental | PRO-172 Ophthalmic Solution QID (four times per day). Single arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepotastine Besilate | Drug | Bepotastine Besilate 1.5% QID (quater in die) for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Related Unexpected Adverse Events (AE) | Presence/absence of related non expected adverse events | Day 10 |
| Ocular Comfort Index | Ocular Comfort Index (OCI) Questionnaire for evaluation of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome. | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Best Corrected Visual Acuity (BCVA) | Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. 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.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad ClÃnica de Bioequivalencia, S. de R.L. de C.V. | Guadalajara | Jalisco | 44190 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | PRO-172 | PRO-172 Ophthalmic Solution QID (four times per day). Single arm. Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
| ID | Title | Description |
|---|---|---|
| BG000 | PRO-172 | PRO-172 Ophthalmic Solution QID (four times per day). Single arm. Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Incidence of Related Unexpected Adverse Events (AE) | Presence/absence of related non expected adverse events | The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify adherence to stipulated procedures in the protocol. | Posted | Number | Number of unexpected related AE | Day 10 |
|
From day 1 (basal visit) to the safety call on day 10 (± 1 days)
The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
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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-172 | PRO-172 Ophthalmic Solution QID (four times per day). Single arm. Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritation in the area of instillation | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alejandra Sanchez-RÃos M.D. | Laboratorios Sophia | :+52 (33) 3001 4200 | 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 | Yes | No | No | Study Protocol | Nov 11, 2019 | May 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2019 | Jun 25, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C511534 | bepotastine besilate |
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Controlled, single center, non comparative
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| Baseline vs Day 8 |
| Conjunctival and Corneal Staining With Lissamine Green | Conjunctival and corneal staining with lissamine green. The evaluation will take place after applying the lissamine green stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V). | Day 8 |
| Conjunctival and Corneal Staining With Fluorescein | Conjunctival and corneal staining with fluorescein. The evaluation will take place after applying the fluorescein tain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V). | Day 8 |
| Conjunctival Hyperemia | Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4). | Day 8 |
| Chemosis Incidence | Chemosis incidence will be evaluated at the end of the treatment at the final visit | Day 8 |
| Eyes |
|
| Participants |
| Participants |
|
|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
|
| Intraocular Pressure (IOP) | Mean | Standard Deviation | mmhg | Eyes |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Ocular Comfort Index | Ocular Comfort Index (OCI) Questionnaire for evaluation of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome. | The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol. | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
|
|
|
| Secondary | Changes in Best Corrected Visual Acuity (BCVA) | Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. 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.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome. | Posted | Mean | Standard Deviation | decimal score (Snellen Chart) | Baseline vs Day 8 |
|
|
|
| Secondary | Conjunctival and Corneal Staining With Lissamine Green | Conjunctival and corneal staining with lissamine green. The evaluation will take place after applying the lissamine green stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V). | The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol. | Posted | Number | percentage of participants | Day 8 |
|
|
|
| Secondary | Conjunctival and Corneal Staining With Fluorescein | Conjunctival and corneal staining with fluorescein. The evaluation will take place after applying the fluorescein tain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V). | The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol. | Posted | Number | percentage of participants | Day 8 |
|
|
|
| Secondary | Conjunctival Hyperemia | Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4). | The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol. | Posted | Number | percentage of eyes | Day 8 | Eyes | Eyes |
|
|
|
| Secondary | Chemosis Incidence | Chemosis incidence will be evaluated at the end of the treatment at the final visit | The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol. | Posted | Count of Participants | Participants | Day 8 |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 17 |
| 22 |
| Burning sensation | Eye disorders | Systematic Assessment |
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| Ocular discharge | Eye disorders | Systematic Assessment |
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| dysgeusia | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| pharyngitis | Gastrointestinal disorders | Systematic Assessment |
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| photophobia | Eye disorders | Systematic Assessment |
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| sore throat | Gastrointestinal disorders | Systematic Assessment |
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| heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| feeling of sticky eye | Eye disorders | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
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