Trial Outcomes & Findings for Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+ (NCT NCT04693429)
NCT ID: NCT04693429
Last Updated: 2025-07-16
Results Overview
Presence/absence of related non expected adverse events
COMPLETED
PHASE1
22 participants
Day 10
2025-07-16
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+
Baseline characteristics by cohort
| Measure |
PRO-172
n=44 Eyes
PRO-172 Ophthalmic Solution QID (four times per day). Single arm.
Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants
|
|
Age, Continuous
|
29.50 years
STANDARD_DEVIATION 7.66 • n=22 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=22 Participants
|
|
Region of Enrollment
Mexico
|
22 Participants
n=22 Participants
|
|
Intraocular Pressure (IOP)
|
13.75 mmhg
STANDARD_DEVIATION 2.19 • n=44 Eyes
|
PRIMARY outcome
Timeframe: Day 10Population: 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.
Presence/absence of related non expected adverse events
Outcome measures
| Measure |
PRO-172
n=22 Participants
PRO-172 Ophthalmic Solution QID (four times per day). Single arm.
Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days
|
|---|---|
|
Incidence of Related Unexpected Adverse Events (AE)
|
12 Number of unexpected related AE
|
PRIMARY outcome
Timeframe: Day 8Population: 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.
Ocular Comfort Index (OCI) Questionnaire for evaluation of dry eye symptoms in a scale from 0 to 100. Greater scores mean a worse outcome.
Outcome measures
| Measure |
PRO-172
n=22 Participants
PRO-172 Ophthalmic Solution QID (four times per day). Single arm.
Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days
|
|---|---|
|
Ocular Comfort Index
|
17.70 score on a scale
Standard Deviation 11.76
|
SECONDARY outcome
Timeframe: Baseline vs Day 8Visual 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.
Outcome measures
| Measure |
PRO-172
n=22 Participants
PRO-172 Ophthalmic Solution QID (four times per day). Single arm.
Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days
|
|---|---|
|
Changes in Best Corrected Visual Acuity (BCVA)
|
0.921 decimal score (Snellen Chart)
Standard Deviation 0.125
|
SECONDARY outcome
Timeframe: Day 8Population: 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.
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).
Outcome measures
| Measure |
PRO-172
n=22 Participants
PRO-172 Ophthalmic Solution QID (four times per day). Single arm.
Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days
|
|---|---|
|
Conjunctival and Corneal Staining With Lissamine Green
Oxford scale: Absent (0)
|
60.5 percentage of participants
|
|
Conjunctival and Corneal Staining With Lissamine Green
Oxford scale: Minimal (I)
|
39.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 8Population: 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.
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).
Outcome measures
| Measure |
PRO-172
n=22 Participants
PRO-172 Ophthalmic Solution QID (four times per day). Single arm.
Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days
|
|---|---|
|
Conjunctival and Corneal Staining With Fluorescein
Oxford scale: Absent (0)
|
81.6 percentage of participants
|
|
Conjunctival and Corneal Staining With Fluorescein
Oxford scale: Minimal (I)
|
13.2 percentage of participants
|
|
Conjunctival and Corneal Staining With Fluorescein
Oxford scale: Mild (II)
|
5.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 8Population: 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.
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).
Outcome measures
| Measure |
PRO-172
n=44 Eyes
PRO-172 Ophthalmic Solution QID (four times per day). Single arm.
Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days
|
|---|---|
|
Conjunctival Hyperemia
the Efron scale: Normal (0)
|
60.5 percentage of eyes
|
|
Conjunctival Hyperemia
the Efron scale: Very Mild (I)
|
39.5 percentage of eyes
|
SECONDARY outcome
Timeframe: Day 8Population: 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.
Chemosis incidence will be evaluated at the end of the treatment at the final visit
Outcome measures
| Measure |
PRO-172
n=22 Participants
PRO-172 Ophthalmic Solution QID (four times per day). Single arm.
Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days
|
|---|---|
|
Chemosis Incidence
|
0 Participants
|
Adverse Events
PRO-172
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PRO-172
n=22 participants at risk
PRO-172 Ophthalmic Solution QID (four times per day). Single arm.
Bepotastine Besilate: Bepotastine Besilate 1.5% QID (quater in die) for 7 days
|
|---|---|
|
Eye disorders
Irritation in the area of instillation
|
31.8%
7/22 • From day 1 (basal visit) to the safety call on day 10 (± 1 days)
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.
|
|
Eye disorders
Burning sensation
|
50.0%
11/22 • From day 1 (basal visit) to the safety call on day 10 (± 1 days)
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.
|
|
Eye disorders
Ocular discharge
|
4.5%
1/22 • From day 1 (basal visit) to the safety call on day 10 (± 1 days)
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.
|
|
Gastrointestinal disorders
dysgeusia
|
40.9%
9/22 • From day 1 (basal visit) to the safety call on day 10 (± 1 days)
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.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • From day 1 (basal visit) to the safety call on day 10 (± 1 days)
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.
|
|
Gastrointestinal disorders
pharyngitis
|
4.5%
1/22 • From day 1 (basal visit) to the safety call on day 10 (± 1 days)
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.
|
|
Eye disorders
photophobia
|
4.5%
1/22 • From day 1 (basal visit) to the safety call on day 10 (± 1 days)
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.
|
|
Gastrointestinal disorders
sore throat
|
4.5%
1/22 • From day 1 (basal visit) to the safety call on day 10 (± 1 days)
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.
|
|
Gastrointestinal disorders
heartburn
|
9.1%
2/22 • From day 1 (basal visit) to the safety call on day 10 (± 1 days)
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.
|
|
Eye disorders
feeling of sticky eye
|
9.1%
2/22 • From day 1 (basal visit) to the safety call on day 10 (± 1 days)
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place