Healthy
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGPRO-156
Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female. * Age between 18 and 40 years old at screening visit. * Signed informed consent
Exclusion criteria
* Patient with one blind eye. * Any ocular or systemic condition. * Visual acuity of 20/100 in any eye. * Use of ocular or systemic medication. * Contraindications or sensitivity to any component of the study treatment. * Contact lens users. * Ocular surgery within the past 3 months.. * Pregnant, nursing or childbearing potential women who were not using effective contraception. * Participation in any studies of investigational drugs within 90 days previous to the inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity (VA) | 11 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cases With Adverse Events | 11 days | The presence of adverse events was evaluated by the number of cases. |
| Intraocular Pressure (IOP) | 11 days | 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. |
| Number of Eyes With Epithelial Defects | 11 days | 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. |
Participant flow
Recruitment details
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.
Pre-assignment details
Only 30 were selected and 2 discarded because they met the exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 60 |
| Total | 90 |
Baseline characteristics
| Characteristic | PRO-156 |
|---|---|
| Age, Continuous | 27 years |
| Race (NIH/OMB) Race American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Race Asian | 0 Participants |
| Race (NIH/OMB) Race Black or African American | 0 Participants |
| Race (NIH/OMB) Race More than one race | 30 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Race White | 0 Participants |
| Region of Enrollment Mexico | 30 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 6 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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
Time frame: 11 days
Population: the analysis by treatment of the research subjects was carried out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO-156 | Visual Acuity (VA) | basal visit | 19.9 score on a scale | Standard Deviation 1.2 |
| PRO-156 | Visual Acuity (VA) | Final visit | 19.83 score on a scale | Standard Deviation 0.9 |
p-value: 0.89Friedman test
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.
Time frame: 11 days
Population: the analysis of the study population was by protocol with Wilcoxon test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO-156 | Intraocular Pressure (IOP) | basal visit | 12.60 mmHg | Standard Deviation 2.47 |
| PRO-156 | Intraocular Pressure (IOP) | Final visit | 12.23 mmHg | Standard Deviation 2.47 |
p-value: 0.078Wilcoxon (Mann-Whitney)
Secondary
Number of Cases With Adverse Events
The presence of adverse events was evaluated by the number of cases.
Time frame: 11 days
Population: the statistical analysis was performed by protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PRO-156 | Number of Cases With Adverse Events | 6 cases |
p-value: 0.497Wilcoxon (Mann-Whitney)
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.
Time frame: 11 days
Population: the statistical analysis was performed by protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PRO-156 | Number of Eyes With Epithelial Defects | 0 eyes |
p-value: 1Friedman test