Trial Outcomes & Findings for Safety and Tolerability of PRO-185 (NCT NCT05470868)
NCT ID: NCT05470868
Last Updated: 2025-07-17
Results Overview
Safety evaluation through the incidence of subjects presenting an IOP elevation comparing Baseline Visit, Final Visit and before and after (20 minutes) research product administration (V1 and V2). Only right-eye values were analyzed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Baseline visit (BV), day 1(pre and post pupil dilation); Visit 1 (V1), day 3 +1 (pre and post research product application); Visit 2 (V2), day 8 (pre and post research product application); Final Visit, day 10 (+1)
Results posted on
2025-07-17
Participant Flow
Participant milestones
| Measure |
PRO-185
Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.
Naphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability of PRO-185
Baseline characteristics by cohort
| Measure |
PRO-185
n=44 Eyes
Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.
Naphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%
|
|---|---|
|
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
|
23.82 years
STANDARD_DEVIATION 4.48 • n=22 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=22 Participants
|
|
Region of Enrollment
Mexico
|
22 Participants
n=22 Participants
|
|
Intraocular Pressure (IOP)
|
14.00 mmhg
STANDARD_DEVIATION 2.80 • n=44 Eyes
|
|
Pupillary diameter
|
6.50 millimeters
STANDARD_DEVIATION 0.47 • n=44 Eyes
|
PRIMARY outcome
Timeframe: Baseline visit (BV), day 1(pre and post pupil dilation); Visit 1 (V1), day 3 +1 (pre and post research product application); Visit 2 (V2), day 8 (pre and post research product application); Final Visit, day 10 (+1)Safety evaluation through the incidence of subjects presenting an IOP elevation comparing Baseline Visit, Final Visit and before and after (20 minutes) research product administration (V1 and V2). Only right-eye values were analyzed.
Outcome measures
| Measure |
PRO-185
n=22 Eyes (right)
Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.
Naphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%
|
|---|---|
|
Intraocular Pressure (IOP) Increment
VB IOP (pre-pupil dilation)
|
14.00 mmhg
Standard Deviation 2.17
|
|
Intraocular Pressure (IOP) Increment
VB IOP (post-pupil dilation)
|
13.57 mmhg
Standard Deviation 2.75
|
|
Intraocular Pressure (IOP) Increment
V1 IOP (pre-research product application)
|
13.47 mmhg
Standard Deviation 2.21
|
|
Intraocular Pressure (IOP) Increment
V1 IOP (post-research product application)
|
13.25 mmhg
Standard Deviation 1.90
|
|
Intraocular Pressure (IOP) Increment
V2 IOP (pre-research product application)
|
13.02 mmhg
Standard Deviation 2.09
|
|
Intraocular Pressure (IOP) Increment
V2 IOP (post-research product application)
|
13.65 mmhg
Standard Deviation 2.63
|
|
Intraocular Pressure (IOP) Increment
FV IOP
|
12.79 mmhg
Standard Deviation 2.17
|
PRIMARY outcome
Timeframe: Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)Safety evaluation through the incidence of subjects presenting an elevation \> 15 beats per minute 20 minutes after administration, in comparison to baseline value.
Outcome measures
| Measure |
PRO-185
n=22 Participants
Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.
Naphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%
|
|---|---|
|
Heart Rate Increment
BV Heart Rate
|
73.27 beats per minute
Standard Deviation 11.31
|
|
Heart Rate Increment
V1 Heart Rate (pre-instillation)
|
70.54 beats per minute
Standard Deviation 7.49
|
|
Heart Rate Increment
V1 Heart Rate (post70.59-instillation)
|
70.59 beats per minute
Standard Deviation 6.03
|
|
Heart Rate Increment
V2 Heart Rate (pre-instillation)
|
70.68 beats per minute
Standard Deviation 5.33
|
|
Heart Rate Increment
V2 Heart Rate (post-instillation)
|
69.90 beats per minute
Standard Deviation 4.61
|
|
Heart Rate Increment
FV Heart Rate
|
73 beats per minute
Standard Deviation 9.19
|
PRIMARY outcome
Timeframe: Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)Safety evaluation through the incidence of subjects presenting an elevation \> 15 mmHg in systolic pressure or \> 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.
Outcome measures
| Measure |
PRO-185
n=22 Participants
Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.
Naphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%
|
|---|---|
|
Blood Pressure Increment (Systolic)
BV Systolic Blood Pressure
|
113.81 mmHg
Standard Deviation 9.09
|
|
Blood Pressure Increment (Systolic)
V1 Systolic Blood Pressure (pre-instillation)
|
111.00 mmHg
Standard Deviation 12.07
|
|
Blood Pressure Increment (Systolic)
V1 Systolic Blood Pressure (post-instillation)
|
111.22 mmHg
Standard Deviation 10.72
|
|
Blood Pressure Increment (Systolic)
V2 Systolic Blood Pressure (pre-instillation)
|
107.50 mmHg
Standard Deviation 10.40
|
|
Blood Pressure Increment (Systolic)
V2 Systolic Blood Pressure (post-instillation)
|
108.63 mmHg
Standard Deviation 9.21
|
|
Blood Pressure Increment (Systolic)
FV Systolic Blood Pressure
|
113.90 mmHg
Standard Deviation 12.14
|
PRIMARY outcome
Timeframe: Trough Day 10 (+1)Tolerability evaluation through the incidence of conjunctival hyperemia grades 3 and 4 (according to the Efron scale). A higher score (grades) in this scale translates into worse outcomes. Only right-eye values were analyzed.
Outcome measures
| Measure |
PRO-185
n=22 Eyes (right)
Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.
Naphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%
|
|---|---|
|
Incidence of Conjunctival Hyperemia
|
2 Number of participants gde 3 or 4 Hypere
|
PRIMARY outcome
Timeframe: Trough Day 10 (+1)Incidence of pharmacological mydriasis measured through OPD III scan. If there was a change greater than 2 mm in pupil diameter between the baseline visit and any of the other measurements, pharmacological mydriasis was considered present, also if there was this change between the pre- and post-examination of the investigational product during visits 1 and 2.
Outcome measures
| Measure |
PRO-185
n=22 Eyes (right)
Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.
Naphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%
|
|---|---|
|
Incidence of Pharmacological Mydriasis
|
6.50 millimeters
Standard Deviation 0.60
|
PRIMARY outcome
Timeframe: Baseline visit, day 1(pre and post pupil dilation); Visit 1, day 3 +1 (pre and post research product application); Visit 2, day 8 (pre and post research product application); Final Visit, day 10 (+1)Safety evaluation through the incidence of subjects presenting an elevation \> 15 mmHg in systolic pressure or \> 10 mmHg in diastolic pressure 20 minutes after administration, in comparison to baseline value.
Outcome measures
| Measure |
PRO-185
n=22 Participants
Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.
Naphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%
|
|---|---|
|
Blood Pressure Increment (Diastolic)
BV Diastolic Blood Pressure
|
68.36 mmHg
Standard Deviation 8.16
|
|
Blood Pressure Increment (Diastolic)
V1 Diastolic Blood Pressure (pre-instillation)
|
68.40 mmHg
Standard Deviation 7.73
|
|
Blood Pressure Increment (Diastolic)
V1 Diastolic Blood Pressure (post-instillation)
|
69.45 mmHg
Standard Deviation 7.2
|
|
Blood Pressure Increment (Diastolic)
V2 Diastolic Blood Pressure (pre-instillation)
|
66.59 mmHg
Standard Deviation 6.54
|
|
Blood Pressure Increment (Diastolic)
V2 Diastolic Blood Pressure (post-instillation)
|
67.31 mmHg
Standard Deviation 7.67
|
|
Blood Pressure Increment (Diastolic)
FV Diastolic Blood Pressure
|
67.41 mmHg
Standard Deviation 7.76
|
Adverse Events
PRO-185
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PRO-185
n=22 participants at risk
Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days.
Naphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2%
|
|---|---|
|
Eye disorders
Burning sensation
|
27.3%
6/22 • From day 1 (basal visit) to final visit 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.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • From day 1 (basal visit) to final visit 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
Tearing
|
9.1%
2/22 • From day 1 (basal visit) to final visit 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
Blurred vision
|
4.5%
1/22 • From day 1 (basal visit) to final visit 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.
|
|
Endocrine disorders
Irritation in the area of instillation
|
4.5%
1/22 • From day 1 (basal visit) to final visit 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
conjunctival hyperemia
|
9.1%
2/22 • From day 1 (basal visit) to final visit 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
punctate keratitis
|
4.5%
1/22 • From day 1 (basal visit) to final visit 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.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place