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Evaluation of the safety and tolerability of PRO-201 (0.01% sulfate atropine) after its instillation on the ocular surface of healthy volunteers through the following variables: unexpected adverse events incidence and photophobia (primary outcome variables); as well as pupillary diameter, expected adverse events incidence, best near corrected visual acuity (BNCVA), best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal and conjunctival staining, heart rate, blood pressure and ocular confort index (OCI),
A total of 29 healthy volunteers will be enrolled in this study. They will receive one drop of the investigation product PRO-201 (0.01% atropine sulfate) once a day (QD) for a total of 14 days on both eyes. A final safety call will be performed one week after the last day of product application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-201 | Experimental | A total of 29 anticipated healthy volunteers will be exposed to the investigation product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine Sulfate | Drug | Administration of one drop QD on both eyes for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Unexpected Adverse Events | The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration. | Through Day 21 ± 1 (Safety Call) |
| Number of Patients With Photophobia | The number of cases of photophobia. | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Pupillary Diameter | Measurement of pupillary diameter after exposure to the investigation product. | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) |
| Percentage of Expected Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Intraocular Pressure (IOP) | The change in IOP after exposure to investigation product, compared to basal value. | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) |
| Number of Cases With Corneal and Conjunctival Staining With Fluorescein |
Inclusion Criteria:
Exclusion Criteria:
Elimination criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IIMET Investigación e Innovación en Medicina Traslacional | Guadalajara | Jalisco | 44610 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | PRO-201 | A total of 29 anticipated healthy volunteers webe exposed to the investigation product (ITT population n=29) The PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%) was comprised by 27 subjects. . Atropine Sulfate: Administration of one drop QD on both eyes for 14 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | PRO-201 | A total of 29 anticipated healthy volunteers will be exposed to the investigation product. Atropine Sulfate: Administration of one drop QD on both eyes for 14 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 | Number of Unexpected Adverse Events | The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration. | 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 | adverse events | Through Day 21 ± 1 (Safety Call) | Eyes | Eyes |
|
From day 1 (basal visit) to the safety call on day 21(±2 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-201 | A total of 29 anticipated healthy volunteers will be exposed to the investigation product. Atropine Sulfate: Administration of one drop QD on both eyes for 14 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning sensation | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alejandra Sanchez-Ríos 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2021 | Feb 4, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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Phase I, controlled, non-comparative, open, unicentric study.
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The percentage of adverse events presented that are expected, or previously described / known for the active substance in this pharmaceutic form and concentration.
| Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit), 21 ± 1 (Safety Call) |
| Measurement of the Change in Best Near Corrected Visual Acuity (BCNVA) | The change in BCNVA after exposure to investigation product, compared to basal value. | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) |
It was graded according to the Sjögren's International Clinical Collaboration Alliance (SICCA) Ocular Staining Score (CTO). According to the CTO, grade 0 corresponds to the absence of punctate epithelial erosions (PEE); grade 1 is defined as the presence of 1-5 EEPs; grade 2 corresponds to 6-30 EEP; and >30 EEP will be classified as grade 3. Additionally, one qualification point will be added if: 1) EEP is present in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches, including linear staining, are observed. A higher score is a worse outcome.
| Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) |
| Measurement of Vital Signs (Systolic Blood Pressure) | The change in blood pressure after exposure to investigation product, compared to basal value. | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) |
| Measurement of Vital Signs (Heart Rate) | The change in heart rate after exposure to investigation product, compared to basal value. | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) |
| Value of the Ocular Comfort Index (OCI) Questionnaire. | 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). A higher score is a worse outcome. Similar to the index for ocular surface diseases, the ocular comfort index (OCI) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms. The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions. | Days: 1 (Basal Visit), 16 ± 1 (Final Visit) |
| Number of Cases With Corneal and Conjunctival Staining With Lissamine Green | It was graded according to the Sjögren's International Clinical Collaboration Alliance (SICCA) Ocular Staining Score (CTO). According to the CTO, grade 0 corresponds to the absence of punctate epithelial erosions (PEE); grade 1 is defined as the presence of 1-5 EEPs; grade 2 corresponds to 6-30 EEP; and >30 EEP will be classified as grade 3. Additionally, one qualification point will be added if: 1) EEP is present in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches, including linear staining, are observed. A higher score is a worse outcome. | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| Intraocular pressure (IOP) | Mean | Standard Deviation | mmhg |
|
|
|
| Primary | Number of Patients With Photophobia | The number of cases of photophobia. | Posted | Count of Participants | Participants | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) |
|
|
|
| Secondary | Pupillary Diameter | Measurement of pupillary diameter after exposure to the investigation product. | Only the right eyes of the participants were analyzed. | Posted | Mean | Standard Deviation | mm | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) | Eyes (right) | Eyes (right) |
|
|
|
| Secondary | Percentage of Expected Adverse Events | The percentage of adverse events presented that are expected, or previously described / known for the active substance in this pharmaceutic form and concentration. | Posted | Number | percentage | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit), 21 ± 1 (Safety Call) | Eyes | Eyes |
|
|
|
| Secondary | Measurement of the Change in Best Near Corrected Visual Acuity (BCNVA) | The change in BCNVA after exposure to investigation product, compared to basal value. | Only the values obtained from the right eyes were analyzed for this variable. | Posted | Mean | Standard Deviation | LogMAR (Snellen Chart) | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) | Eyes (right) | Eyes (right) |
|
|
|
| Other Pre-specified | Changes in Intraocular Pressure (IOP) | The change in IOP after exposure to investigation product, compared to basal value. | Only the values obtained from the right eyes were analyzed for this variable. The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%). | Posted | Mean | Standard Deviation | mmHg | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) | Eyes (right) | Eyes (right) |
|
|
|
| Other Pre-specified | Number of Cases With Corneal and Conjunctival Staining With Fluorescein | It was graded according to the Sjögren's International Clinical Collaboration Alliance (SICCA) Ocular Staining Score (CTO). According to the CTO, grade 0 corresponds to the absence of punctate epithelial erosions (PEE); grade 1 is defined as the presence of 1-5 EEPs; grade 2 corresponds to 6-30 EEP; and >30 EEP will be classified as grade 3. Additionally, one qualification point will be added if: 1) EEP is present in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches, including linear staining, are observed. A higher score is a worse outcome. | Only the values obtained from the right eyes were analyzed for this variable. The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%). | Posted | Number | Eyes (right) | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) | Eyes (right) | Eyes (right) |
|
|
|
| Other Pre-specified | Measurement of Vital Signs (Systolic Blood Pressure) | The change in blood pressure after exposure to investigation product, compared to basal value. | The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%). | Posted | Mean | Standard Deviation | mmHg | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) |
|
|
|
| Other Pre-specified | Measurement of Vital Signs (Heart Rate) | The change in heart rate after exposure to investigation product, compared to basal value. | The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%). | Posted | Mean | Standard Deviation | pulse per minutes | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) |
|
|
|
| Other Pre-specified | Value of the Ocular Comfort Index (OCI) Questionnaire. | 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). A higher score is a worse outcome. Similar to the index for ocular surface diseases, the ocular comfort index (OCI) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms. The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions. | The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%). | Posted | Mean | Standard Deviation | scores on a scale | Days: 1 (Basal Visit), 16 ± 1 (Final Visit) |
|
|
|
| Other Pre-specified | Number of Cases With Corneal and Conjunctival Staining With Lissamine Green | It was graded according to the Sjögren's International Clinical Collaboration Alliance (SICCA) Ocular Staining Score (CTO). According to the CTO, grade 0 corresponds to the absence of punctate epithelial erosions (PEE); grade 1 is defined as the presence of 1-5 EEPs; grade 2 corresponds to 6-30 EEP; and >30 EEP will be classified as grade 3. Additionally, one qualification point will be added if: 1) EEP is present in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches, including linear staining, are observed. A higher score is a worse outcome. | Only the values obtained from the right eyes were analyzed for this variable. The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%). | Posted | Number | Eyes (right) | Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit) | Eyes (right) | Eyes (right) |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 21 |
| 29 |
| Foreign body sensation | Eye disorders | Systematic Assessment |
|
| irritation in the area of instillation | Eye disorders | Systematic Assessment |
|
| Blurred vision | Eye disorders | Systematic Assessment |
|
| Ocular hyperemia | Eye disorders | Systematic Assessment |
|
| Pruritus | Eye disorders | Systematic Assessment |
|
| Tearing | Eye disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| decreased visual acuity | Eye disorders | Systematic Assessment |
|
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| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| No Photophobia |
|
| Final visit |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| V1 corneal and conjunctival staining with fluorescein : Grade 1 |
|
| FV corneal and conjunctival staining with fluorescein : Grade 0 |
|
| FV corneal and conjunctival staining with fluorescein : Grade 1 |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| V1 Corneal and conjunctival staining with lissamine green : Grade 0 |
|
| V1 Corneal and conjunctival staining with lissamine green : Grade 1 |
|
| V1 Corneal and conjunctival staining with lissamine green : Grade 2 |
|
| FV Corneal and conjunctival staining with lissamine green : Grade 0 |
|
| FV Corneal and conjunctival staining with lissamine green : Grade 1 |
|
| FV Corneal and conjunctival staining with lissamine green : Grade 2 |
|