Safety, Tolerability, Ocular Surface, Ocular Comfort
Conditions
Brief summary
Clinical phase I, controlled, non comparative, open, single center study evaluating the safety and tolerability of ophthalmic solution PRO-172 when applied on the ocular surface of healthy volunteers.
Interventions
Bepotastine Besilate 1.5% QID (quater in die) for 7 days
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Controlled, single center, non comparative
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinically healthy volunteers * Being capable of voluntarily grant a signed informed consent. * Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures. * Being between 18 and 45 years old. * Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method of intrauterine device (IUD) during the study. * Having a best corrected visual acuity equal or better than 20/30 in both eyes. * Showing normal vital signs. * Having an intraocular pressure between 10 and 21 mmHg.
Exclusion criteria
* Using any kind of ophthalmic topical product. * Using drugs or herbal products, through any administration route. * For women: pregnancy, breastfeeding or planning to become pregnant during the time of the study. * Having participated in clinical trials 90 days prior to inclusion in this study. * Having participated previously in this study. * Using contact lenses and not being able to suspend such use during the period of the study. * Being unable to follow the lifestyle modification considerations required for the study. * Having started the use of hormonal contraceptives of IUD within 30 days previous of inclusion in this study. * Suffering any chronic degenerative diseases. * Suffering active inflammatory of infectious disease when entering this study. * Suffering unresolved lesions or traumas when entering this study. * Having a previous history of any kind of ocular surgery. * Having a previous history of any surgical procedure, non ophthalmological, within the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Related Unexpected Adverse Events (AE) | Day 10 | Presence/absence of related non expected adverse events |
| Ocular Comfort Index | Day 8 | Ocular Comfort Index (OCI) Questionnaire for evaluation of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival and Corneal Staining With Fluorescein | Day 8 | Conjunctival and corneal staining with fluorescein. The evaluation will take place after applying the fluorescein tain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V). |
| Changes in Best Corrected Visual Acuity (BCVA) | Baseline vs Day 8 | Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome. |
| Chemosis Incidence | Day 8 | Chemosis incidence will be evaluated at the end of the treatment at the final visit |
| Conjunctival Hyperemia | Day 8 | Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4). |
| Conjunctival and Corneal Staining With Lissamine Green | Day 8 | Conjunctival and corneal staining with lissamine green. The evaluation will take place after applying the lissamine green stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V). |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PRO-172 PRO-172 Ophthalmic Solution QID (four times per day). Single arm.
Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days | 22 |
| PRO-172 PRO-172 Ophthalmic Solution QID (four times per day). Single arm.
Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days | 44 |
| Total | 66 |
Baseline characteristics
| Characteristic | PRO-172 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Age, Continuous | 29.50 years STANDARD_DEVIATION 7.66 |
| Intraocular Pressure (IOP) | 13.75 mmhg STANDARD_DEVIATION 2.19 |
| Region of Enrollment Mexico | 22 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 17 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Incidence of Related Unexpected Adverse Events (AE)
Presence/absence of related non expected adverse events
Time frame: Day 10
Population: 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 adherence to stipulated procedures in the protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PRO-172 | Incidence of Related Unexpected Adverse Events (AE) | 12 Number of unexpected related AE |
Primary
Ocular Comfort Index
Ocular Comfort Index (OCI) Questionnaire for evaluation of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.
Time frame: Day 8
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRO-172 | Ocular Comfort Index | 17.70 score on a scale | Standard Deviation 11.76 |
Secondary
Changes in Best Corrected Visual Acuity (BCVA)
Visual acuity (VA) is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, VA is expressed in decimal format. In decimal format, a lower number is a worse outcome.
Time frame: Baseline vs Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRO-172 | Changes in Best Corrected Visual Acuity (BCVA) | 0.921 decimal score (Snellen Chart) | Standard Deviation 0.125 |
Secondary
Chemosis Incidence
Chemosis incidence will be evaluated at the end of the treatment at the final visit
Time frame: Day 8
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRO-172 | Chemosis Incidence | 0 Participants |
Secondary
Conjunctival and Corneal Staining With Fluorescein
Conjunctival and corneal staining with fluorescein. The evaluation will take place after applying the fluorescein tain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).
Time frame: Day 8
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-172 | Conjunctival and Corneal Staining With Fluorescein | Oxford scale: Absent (0) | 81.6 percentage of participants |
| PRO-172 | Conjunctival and Corneal Staining With Fluorescein | Oxford scale: Minimal (I) | 13.2 percentage of participants |
| PRO-172 | Conjunctival and Corneal Staining With Fluorescein | Oxford scale: Mild (II) | 5.3 percentage of participants |
Secondary
Conjunctival and Corneal Staining With Lissamine Green
Conjunctival and corneal staining with lissamine green. The evaluation will take place after applying the lissamine green stain on the ocular surface and evaluating the resulting staining pattern. This will be measured through the Oxford scale which includes 6 grades: Absent (0), Minimal (I), Mild (II), Moderate (III), Marked (IV), Severe (V).
Time frame: Day 8
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-172 | Conjunctival and Corneal Staining With Lissamine Green | Oxford scale: Absent (0) | 60.5 percentage of participants |
| PRO-172 | Conjunctival and Corneal Staining With Lissamine Green | Oxford scale: Minimal (I) | 39.5 percentage of participants |
Secondary
Conjunctival Hyperemia
Rate of conjunctival hyperemia will be evaluated through the Efron scale which includes 5 grades: Normal (0), Very Mild (I), Mild (II), Moderate (3), and Severe (4).
Time frame: Day 8
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-172 | Conjunctival Hyperemia | the Efron scale: Normal (0) | 60.5 percentage of eyes |
| PRO-172 | Conjunctival Hyperemia | the Efron scale: Very Mild (I) | 39.5 percentage of eyes |