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Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.
A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bromfenac | Experimental | Drug: Bromfenac ophthalmic solution 1 drop 4 times per day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromfenac | Drug | Drug: Bromfenac Other names: PRO-155 |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | will be reported the presence of adverse events presented in the study group during the intervention period . | 10 days |
| Findings in Posterior Segment | Abnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfredo Lizarraga-Corona, MD | Unidad Medica "Grupo Pediátrico" | Principal Investigator |
| Leopoldo M Baiza-Duran, MD | Clinical Research Department. Laboratorios Sophia SA de CV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad Medica "Grupo Pediátrico" | Guadalajara | Jalisco | 44690 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | PRO-155 Ophthalmic Solution 0.09 % | PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days.. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PRO-155 Ophthalmic Solution 0.09 % | PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice to day during 10 days.. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Visual Acuity | A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst | Per protocol | Posted | Mean | Standard Deviation | units on a scale | 10 days | eyes | eyes |
|
|
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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-155 Ophthalmic Solution 0.09 % | PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice to day during 10 days.. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Baiza-Duran Leopoldo, Medial Director | Laboratorios Sophia, SA de CV | +52 (33)30014200 | lbaiza@sophia.com.mx |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C053083 | bromfenac |
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| 10 days |
| Intraocular Pressure (IOP) | Intraocular pressure (IOP) measurement by applanation tonometry. The unit of measurement will be millimeters of mercury (mmhg) the normal range will be considered 11 to 21 mmhg. | 10 days |
| Hyperemia | The red eye will be evaluated by the absence or presence of hyperemia. | 10 days |
| Burning | Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe. | 10 days |
| Tearing | Tearing will be reported according to the following scale: absent, mild, moderate and severe. | 10 days |
| Foreign Body Sensation | Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe. | 10 days |
| Photophobia | photophobia will be reported according to the following scale: absent, mild, moderate and severe. | 10 days |
| Chemosis | chemosis will be reported according to the following scale: absent, mild, moderate and severe. | 10 days |
| Corneal Damage by Fluorescein Staining Test | Corneal damage will be reported by Fluorescein eye staining using the following scale: absent, mild, moderate, and severe. | 10 days |
| Corneal Damage by Lissamine Green Staining Test | Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe. | 10 days |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| eyes |
|
|
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| Secondary | Adverse Events | will be reported the presence of adverse events presented in the study group during the intervention period . | Analysis by intention to treat (ITT) | Posted | Number | events | 10 days | eyes | eyes |
|
|
|
| Secondary | Findings in Posterior Segment | Abnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings. | Posted | Number | abnormal findings | 10 days | eyes | eyes |
|
|
|
| Secondary | Intraocular Pressure (IOP) | Intraocular pressure (IOP) measurement by applanation tonometry. The unit of measurement will be millimeters of mercury (mmhg) the normal range will be considered 11 to 21 mmhg. | Analyze by intention to treat | Posted | Mean | Standard Deviation | millimeters of mercury (mmhg) | 10 days |
|
|
|
| Secondary | Hyperemia | The red eye will be evaluated by the absence or presence of hyperemia. | Intention to treat analysis (ITT) | Posted | Number | eyes | 10 days |
|
|
|
| Secondary | Burning | Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe. | Intention-to-treat analysis (ITT) | Posted | Number | eyes | 10 days | eyes | eyes |
|
|
|
| Secondary | Tearing | Tearing will be reported according to the following scale: absent, mild, moderate and severe. | Intention-to-treat analysis (ITT) | Posted | Number | eyes | 10 days | eyes | eyes |
|
|
|
| Secondary | Foreign Body Sensation | Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe. | Intention-to-treat analysis (ITT) | Posted | Number | eyes | 10 days | eyes | eyes |
|
|
|
| Secondary | Photophobia | photophobia will be reported according to the following scale: absent, mild, moderate and severe. | Intention-to-treat analysis (ITT) | Posted | Number | eyes | 10 days | eyes | eyes |
|
|
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| Secondary | Chemosis | chemosis will be reported according to the following scale: absent, mild, moderate and severe. | Intention-to-treat analysis (ITT) | Posted | Number | eyes | 10 days | eyes | eyes |
|
|
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| Secondary | Corneal Damage by Fluorescein Staining Test | Corneal damage will be reported by Fluorescein eye staining using the following scale: absent, mild, moderate, and severe. | Intention-to-treat analysis (ITT) | Posted | Number | eyes | 10 days | eyes | eyes |
|
|
|
| Secondary | Corneal Damage by Lissamine Green Staining Test | Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe. | Intention-to-treat analysis (ITT) | Posted | Number | eyes | 10 days | eyes | eyes |
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|
| 0 |
| 35 |
| 0 |
| 35 |
All the information is confidential and exclusive property of the sponsor. Information can be revealed only to my staff and regulatory agencies or ethics committee.
All the information from this protocol is confidential and exclusive property of the sponsor, it can not be revealed without written consent from the sponsor.
| Title | Measurements |
|---|---|
|
| right eye : severe |
|
| left eye : absent |
|
| left eye : mild |
|
| left eye : moderate |
|
| left eye : severe |
|
| Title | Measurements |
|---|---|
|
| right eye : severe |
|
| left eye : absent |
|
| left eye : mild |
|
| left eye : moderate |
|
| left eye : severe |
|
| left eye : Missing data |
|
| right eye : Missing data |
|
| Title | Measurements |
|---|---|
|
| right eye : severe |
|
| left eye : absent |
|
| left eye : mild |
|
| left eye : moderate |
|
| left eye : severe |
|
| left eye: Missing data |
|
| right eye : Missing data |
|
| Title | Measurements |
|---|---|
|
| right eye : severe |
|
| left eye : absent |
|
| left eye : mild |
|
| left eye : moderate |
|
| left eye : severe |
|
| left eye : Missing data |
|
| right eye : Missing data |
|
| Title | Measurements |
|---|---|
|
| right eye : severe |
|
| left eye : absent |
|
| left eye : mild |
|
| left eye : moderate |
|
| left eye : severe |
|
| left eye : Missing data |
|
| right eye : Missing data |
|
| Title | Measurements |
|---|---|
|
| right eye : severe |
|
| left eye : absent |
|
| left eye : mild |
|
| left eye : moderate |
|
| left eye : severe |
|
| left eye : Missing data |
|
| right eye : Missing data |
|
| Title | Measurements |
|---|---|
|
| right eye : severe |
|
| left eye : absent |
|
| left eye : mild |
|
| left eye : moderate |
|
| left eye : severe |
|
| left eye : Missing data |
|
| right eye : Missing data |
|