Inflammation, Cataract
Conditions
Keywords
PRO-155, Ocular NSAIDs, Safety and tolerability, Ocular Inflammation, Ocular Paint
Brief summary
Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.
Detailed description
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.
Interventions
DRUGBromfenac
Drug: Bromfenac Other names: PRO-155
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 No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female. * Age ≥ 18 years old at screening visit
Exclusion criteria
* Any ocular or systemic condition. * Patient with one blind eye. * Visual acuity of 20/40 in any eye. * Use of ocular or systemic medications. * Contraindications or sensitivity to any component of the study treatments. * Contact lens users. * Ocular surgery within the past 3 months.. * Women who were not using an effective means of contraception or who were pregnant or nursing. * Participation in any studies of investigational drugs within 90 days previous to the inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 10 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 10 days | will be reported the presence of adverse events presented in the study group during the intervention period . |
| Findings in Posterior Segment | 10 days | Abnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings. |
| Intraocular Pressure (IOP) | 10 days | 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. |
| Hyperemia | 10 days | The red eye will be evaluated by the absence or presence of hyperemia. |
| Burning | 10 days | Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe. |
| Tearing | 10 days | Tearing will be reported according to the following scale: absent, mild, moderate and severe. |
| Foreign Body Sensation | 10 days | Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe. |
| Photophobia | 10 days | photophobia will be reported according to the following scale: absent, mild, moderate and severe. |
| Chemosis | 10 days | chemosis will be reported according to the following scale: absent, mild, moderate and severe. |
| Corneal Damage by Fluorescein Staining Test | 10 days | Corneal damage will be reported by Fluorescein eye staining using the following scale: absent, mild, moderate, and severe. |
| Corneal Damage by Lissamine Green Staining Test | 10 days | Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
Baseline characteristics
| Characteristic | PRO-155 Ophthalmic Solution 0.09 % |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Age, Continuous | 29.8 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment Mexico | 35 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
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
Time frame: 10 days
Population: Per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO-155 Ophthalmic Solution 0.09 % | Visual Acuity | right eye | 20.3 units on a scale | Standard Deviation 1.2 |
| PRO-155 Ophthalmic Solution 0.09 % | Visual Acuity | left eye | 20.2 units on a scale | Standard Deviation 0.9 |
p-value: 0.374Traza Pillai
Secondary
Adverse Events
will be reported the presence of adverse events presented in the study group during the intervention period .
Time frame: 10 days
Population: Analysis by intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PRO-155 Ophthalmic Solution 0.09 % | Adverse Events | 1 events |
Secondary
Burning
Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe.
Time frame: 10 days
Population: Intention-to-treat analysis (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 Ophthalmic Solution 0.09 % | Burning | right eye : absent | 34 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Burning | right eye : mild | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Burning | right eye : moderate | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Burning | right eye : severe | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Burning | left eye : absent | 33 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Burning | left eye : mild | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Burning | left eye : moderate | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Burning | left eye : severe | 1 eyes |
Secondary
Chemosis
chemosis will be reported according to the following scale: absent, mild, moderate and severe.
Time frame: 10 days
Population: Intention-to-treat analysis (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 Ophthalmic Solution 0.09 % | Chemosis | right eye : severe | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Chemosis | left eye : absent | 34 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Chemosis | left eye : mild | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Chemosis | left eye : moderate | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Chemosis | left eye : severe | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Chemosis | left eye : Missing data | 1 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Chemosis | right eye : Missing data | 1 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Chemosis | right eye : absent | 34 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Chemosis | right eye : mild | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Chemosis | right eye : moderate | 0 eyes |
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.
Time frame: 10 days
Population: Intention-to-treat analysis (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Fluorescein Staining Test | right eye : absent | 34 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Fluorescein Staining Test | right eye : mild | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Fluorescein Staining Test | right eye : moderate | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Fluorescein Staining Test | right eye : severe | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Fluorescein Staining Test | left eye : absent | 34 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Fluorescein Staining Test | left eye : mild | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Fluorescein Staining Test | left eye : moderate | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Fluorescein Staining Test | left eye : severe | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Fluorescein Staining Test | left eye : Missing data | 1 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Fluorescein Staining Test | right eye : Missing data | 1 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.
Time frame: 10 days
Population: Intention-to-treat analysis (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Lissamine Green Staining Test | right eye : absent | 34 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Lissamine Green Staining Test | right eye : mild | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Lissamine Green Staining Test | right eye : moderate | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Lissamine Green Staining Test | right eye : severe | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Lissamine Green Staining Test | left eye : absent | 34 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Lissamine Green Staining Test | left eye : moderate | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Lissamine Green Staining Test | left eye : severe | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Lissamine Green Staining Test | left eye : Missing data | 1 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Lissamine Green Staining Test | right eye : Missing data | 1 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Corneal Damage by Lissamine Green Staining Test | left eye : mild | 0 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.
Time frame: 10 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 Ophthalmic Solution 0.09 % | Findings in Posterior Segment | right eye | 1 abnormal findings |
| PRO-155 Ophthalmic Solution 0.09 % | Findings in Posterior Segment | left eye | 1 abnormal findings |
Secondary
Foreign Body Sensation
Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe.
Time frame: 10 days
Population: Intention-to-treat analysis (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 Ophthalmic Solution 0.09 % | Foreign Body Sensation | right eye : absent | 34 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Foreign Body Sensation | right eye : mild | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Foreign Body Sensation | right eye : moderate | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Foreign Body Sensation | right eye : severe | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Foreign Body Sensation | left eye : absent | 34 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Foreign Body Sensation | left eye : mild | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Foreign Body Sensation | left eye : moderate | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Foreign Body Sensation | left eye : severe | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Foreign Body Sensation | left eye: Missing data | 1 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Foreign Body Sensation | right eye : Missing data | 1 eyes |
Secondary
Hyperemia
The red eye will be evaluated by the absence or presence of hyperemia.
Time frame: 10 days
Population: Intention to treat analysis (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 Ophthalmic Solution 0.09 % | Hyperemia | right eye | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Hyperemia | left eye | 0 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.
Time frame: 10 days
Population: Analyze by intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO-155 Ophthalmic Solution 0.09 % | Intraocular Pressure (IOP) | right aye | 13.3 millimeters of mercury (mmhg) | Standard Deviation 2.1 |
| PRO-155 Ophthalmic Solution 0.09 % | Intraocular Pressure (IOP) | left eye | 13.4 millimeters of mercury (mmhg) | Standard Deviation 2 |
Secondary
Photophobia
photophobia will be reported according to the following scale: absent, mild, moderate and severe.
Time frame: 10 days
Population: Intention-to-treat analysis (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 Ophthalmic Solution 0.09 % | Photophobia | left eye : mild | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Photophobia | left eye : moderate | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Photophobia | left eye : severe | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Photophobia | left eye : Missing data | 1 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Photophobia | right eye : Missing data | 1 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Photophobia | right eye : absent | 34 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Photophobia | right eye : mild | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Photophobia | right eye : moderate | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Photophobia | right eye : severe | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Photophobia | left eye : absent | 34 eyes |
Secondary
Tearing
Tearing will be reported according to the following scale: absent, mild, moderate and severe.
Time frame: 10 days
Population: Intention-to-treat analysis (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 Ophthalmic Solution 0.09 % | Tearing | right eye : absent | 34 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Tearing | right eye : mild | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Tearing | right eye : moderate | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Tearing | right eye : severe | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Tearing | left eye : absent | 34 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Tearing | left eye : mild | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Tearing | left eye : moderate | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Tearing | left eye : severe | 0 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Tearing | left eye : Missing data | 1 eyes |
| PRO-155 Ophthalmic Solution 0.09 % | Tearing | right eye : Missing data | 1 eyes |