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The purpose of this study is to evaluate safety and tolerability of the ophthalmic solution PRO-156 over the ocular surface of ophthalmologically healthy volunteers
A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of the ophthalmic solution PRO-143 over the ocular surface of ophthalmologically healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-156 | Experimental | Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-156 | Drug | Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (VA) | The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing "normal" acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less. Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10. the results will be expressed as the mean of the denominator of the Snellen scale (scale 20/--) example. 18.5 ± 1.5, that means the final result is 20/18.5 ± 1.5 | 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | The tension of a healthy eye should be between 10 and 20 millimeters of mercury (mmHg). In Goldman-type Applying Tonometry, the cornea is flattened, and the intraocular pressure is determined by measuring the force of application and the flattened area. | 11 days |
| Number of Eyes With Epithelial Defects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauricio Casillas, MD | Independent Clinical Research Center | Principal Investigator |
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Only 30 were selected and 2 discarded because they met the exclusion criteria.
A total of 32 ophthalmologically healthy volunteers were evaluated, to which both eyes, with no history of any systemic or ophthalmological disease, who were not using any type of medication, and who agreed to participate in the study and met all the inclusion criteria described in the section.
| ID | Title | Description |
|---|---|---|
| FG000 | PRO-156 | Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study population consisted of ophthalmologically healthy volunteers, with no history of any systemic or ophthalmological disease, with both ayes, who were not using any type of medication, and who agreed to participate in the study and met all the inclusion criteria described in the section and with none of the exclusion criteria.
| ID | Title | Description |
|---|---|---|
| BG000 | PRO-156 | Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 (VA) | The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing "normal" acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less. Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10. the results will be expressed as the mean of the denominator of the Snellen scale (scale 20/--) example. 18.5 ± 1.5, that means the final result is 20/18.5 ± 1.5 | the analysis by treatment of the research subjects was carried out | Posted | Mean | Standard Deviation | score on a scale | 11 days | eyes | eyes |
|
The evaluation period was throughout the study (13 days) comprising 11 days of intervention plus 2 days of safety call
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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-156 | Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash | Skin and subcutaneous tissue disorders | skin rash | Systematic Assessment | rash located on the neck and face of the patient of a few hours duration, treated with a single dose of loratadine 10 mg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PhD. Ricardo Llamas | Laboratorios Sophia | +52 (33) 3001 4200 | 1259 | drricardollamas@gmail.com |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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the number of epithelial defects was evaluated by the application of fluorescein, Staining was performed with fluorescein which stained the degenerated cells and the mucus filaments present in the tear film. |
| 11 days |
| Number of Cases With Adverse Events | The presence of adverse events was evaluated by the number of cases. | 11 days |
| eyes |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| OG000 | PRO-156 | Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. PRO-156: Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days. |
|
|
|
| Secondary | Intraocular Pressure (IOP) | The tension of a healthy eye should be between 10 and 20 millimeters of mercury (mmHg). In Goldman-type Applying Tonometry, the cornea is flattened, and the intraocular pressure is determined by measuring the force of application and the flattened area. | the analysis of the study population was by protocol with Wilcoxon test | Posted | Mean | Standard Deviation | mmHg | 11 days | eyes | eyes |
|
|
|
|
| Secondary | Number of Eyes With Epithelial Defects | the number of epithelial defects was evaluated by the application of fluorescein, Staining was performed with fluorescein which stained the degenerated cells and the mucus filaments present in the tear film. | the statistical analysis was performed by protocol | Posted | Number | eyes | 11 days | eyes | eyes |
|
|
|
|
| Secondary | Number of Cases With Adverse Events | The presence of adverse events was evaluated by the number of cases. | the statistical analysis was performed by protocol | Posted | Number | cases | 11 days | eyes | eyes |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 6 |
| 30 |
|
| ocular burning | Eye disorders | Systematic Assessment |
|
| Tearing | Eye disorders | Systematic Assessment |
|
| Red Eye | Eye disorders | Systematic Assessment |
|
| eye pruritus | Eye disorders | Systematic Assessment |
|
| Foreign body sensation in the eyes | Eye disorders | Systematic Assessment |
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by contract only the sponsor has the rights to the results of the study, if the principal researcher wishes the publication or discuss for dissemination of the same can only perform them prior written authorization with the sponsor and its legal department.
| D006571 | Heterocyclic Compounds |