Trial Outcomes & Findings for Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201 (NCT NCT05470881)
NCT ID: NCT05470881
Last Updated: 2026-02-05
Results Overview
The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
COMPLETED
PHASE1
29 participants
Through Day 21 ± 1 (Safety Call)
2026-02-05
Participant Flow
Participant milestones
| Measure |
PRO-201
A total of 29 anticipated healthy volunteers webe exposed to the investigation product (ITT population n=29) The PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%) was comprised by 27 subjects. .
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
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Overall Study
STARTED
|
29
|
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Overall Study
COMPLETED
|
27
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Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
PRO-201
A total of 29 anticipated healthy volunteers webe exposed to the investigation product (ITT population n=29) The PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%) was comprised by 27 subjects. .
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
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|---|---|
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Overall Study
Adherence under 90%
|
2
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PRO-201
n=29 Participants
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=29 Participants
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Age, Categorical
Between 18 and 65 years
|
29 Participants
n=29 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=29 Participants
|
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Age, Continuous
|
22.033 years
STANDARD_DEVIATION 3.61 • n=29 Participants
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Sex: Female, Male
Female
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19 Participants
n=29 Participants
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Sex: Female, Male
Male
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10 Participants
n=29 Participants
|
|
Region of Enrollment
Mexico
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29 participants
n=29 Participants
|
|
Intraocular pressure (IOP)
|
14.67 mmhg
STANDARD_DEVIATION 2.67 • n=29 Participants
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PRIMARY outcome
Timeframe: Through Day 21 ± 1 (Safety Call)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.
The number of adverse events presented that are not previously described / known for the active substance in this pharmaceutic form and concentration.
Outcome measures
| Measure |
PRO-201
n=58 Eyes
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
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Number of Unexpected Adverse Events
|
41 adverse events
|
PRIMARY outcome
Timeframe: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)The number of cases of photophobia.
Outcome measures
| Measure |
PRO-201
n=29 Participants
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
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Number of Patients With Photophobia
Basal Visit · Photophobia
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0 Participants
|
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Number of Patients With Photophobia
Basal Visit · No Photophobia
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29 Participants
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Number of Patients With Photophobia
Visit 1 · Photophobia
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5 Participants
|
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Number of Patients With Photophobia
Visit 1 · No Photophobia
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24 Participants
|
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Number of Patients With Photophobia
Final visit · Photophobia
|
2 Participants
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Number of Patients With Photophobia
Final visit · No Photophobia
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27 Participants
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SECONDARY outcome
Timeframe: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)Population: Only the right eyes of the participants were analyzed.
Measurement of pupillary diameter after exposure to the investigation product.
Outcome measures
| Measure |
PRO-201
n=29 Eyes (right)
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
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Pupillary Diameter
BV pupillary diameter
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3.44 mm
Standard Deviation 0.44
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|
Pupillary Diameter
V1 pupillary diameter
|
3.95 mm
Standard Deviation 0.60
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|
Pupillary Diameter
FV pupillary diameter
|
3.94 mm
Standard Deviation 0.52
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SECONDARY outcome
Timeframe: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit), 21 ± 1 (Safety Call)The percentage of adverse events presented that are expected, or previously described / known for the active substance in this pharmaceutic form and concentration.
Outcome measures
| Measure |
PRO-201
n=58 Eyes
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
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Percentage of Expected Adverse Events
|
92.7 percentage
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SECONDARY outcome
Timeframe: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)Population: Only the values obtained from the right eyes were analyzed for this variable.
The change in BCNVA after exposure to investigation product, compared to basal value.
Outcome measures
| Measure |
PRO-201
n=29 Eyes (right)
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
|
Measurement of the Change in Best Near Corrected Visual Acuity (BCNVA)
FV BCNVA
|
0.01 LogMAR (Snellen Chart)
Standard Deviation 0.02
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Measurement of the Change in Best Near Corrected Visual Acuity (BCNVA)
BV BCNVA
|
0.00 LogMAR (Snellen Chart)
Standard Deviation 0.02
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Measurement of the Change in Best Near Corrected Visual Acuity (BCNVA)
V1 BCNVA
|
0.00 LogMAR (Snellen Chart)
Standard Deviation 0.02
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OTHER_PRE_SPECIFIED outcome
Timeframe: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)Population: Only the values obtained from the right eyes were analyzed for this variable. The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%).
The change in IOP after exposure to investigation product, compared to basal value.
Outcome measures
| Measure |
PRO-201
n=27 Eyes (right)
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
|
Changes in Intraocular Pressure (IOP)
VB IOP
|
14.67 mmHg
Standard Deviation 2.67
|
|
Changes in Intraocular Pressure (IOP)
V1 IOP
|
14.04 mmHg
Standard Deviation 1.91
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|
Changes in Intraocular Pressure (IOP)
FV IOP
|
14.02 mmHg
Standard Deviation 2.32
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OTHER_PRE_SPECIFIED outcome
Timeframe: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)Population: Only the values obtained from the right eyes were analyzed for this variable. The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%).
It was graded according to the Sjögren's International Clinical Collaboration Alliance (SICCA) Ocular Staining Score (CTO). According to the CTO, grade 0 corresponds to the absence of punctate epithelial erosions (PEE); grade 1 is defined as the presence of 1-5 EEPs; grade 2 corresponds to 6-30 EEP; and \>30 EEP will be classified as grade 3. Additionally, one qualification point will be added if: 1) EEP is present in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches, including linear staining, are observed. A higher score is a worse outcome.
Outcome measures
| Measure |
PRO-201
n=27 Eyes (right)
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
|
Number of Cases With Corneal and Conjunctival Staining With Fluorescein
BV corneal and conjunctival staining with fluorescein : Grade 0
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27 Eyes (right)
|
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Number of Cases With Corneal and Conjunctival Staining With Fluorescein
BV corneal and conjunctival staining with fluorescein : Grade 1
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0 Eyes (right)
|
|
Number of Cases With Corneal and Conjunctival Staining With Fluorescein
V1 corneal and conjunctival staining with fluorescein : Grade 0
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26 Eyes (right)
|
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Number of Cases With Corneal and Conjunctival Staining With Fluorescein
V1 corneal and conjunctival staining with fluorescein : Grade 1
|
1 Eyes (right)
|
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Number of Cases With Corneal and Conjunctival Staining With Fluorescein
FV corneal and conjunctival staining with fluorescein : Grade 0
|
26 Eyes (right)
|
|
Number of Cases With Corneal and Conjunctival Staining With Fluorescein
FV corneal and conjunctival staining with fluorescein : Grade 1
|
1 Eyes (right)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%).
The change in blood pressure after exposure to investigation product, compared to basal value.
Outcome measures
| Measure |
PRO-201
n=27 Participants
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
|
Measurement of Vital Signs (Systolic Blood Pressure)
BV Systolic Blood Pressure
|
119.74 mmHg
Standard Deviation 8.73
|
|
Measurement of Vital Signs (Systolic Blood Pressure)
V1 BV Systolic Blood Pressure
|
120.96 mmHg
Standard Deviation 6.14
|
|
Measurement of Vital Signs (Systolic Blood Pressure)
FV BV Systolic Blood Pressure
|
119.41 mmHg
Standard Deviation 7.48
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%).
The change in heart rate after exposure to investigation product, compared to basal value.
Outcome measures
| Measure |
PRO-201
n=27 Participants
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
|
Measurement of Vital Signs (Heart Rate)
BV Heart Rate
|
70.93 pulse per minutes
Standard Deviation 6.62
|
|
Measurement of Vital Signs (Heart Rate)
V1 Heart Rate
|
73.15 pulse per minutes
Standard Deviation 9.51
|
|
Measurement of Vital Signs (Heart Rate)
FV Heart Rate
|
74.93 pulse per minutes
Standard Deviation 8.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days: 1 (Basal Visit), 16 ± 1 (Final Visit)Population: The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%).
It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100). A higher score is a worse outcome. Similar to the index for ocular surface diseases, the ocular comfort index (OCI) evaluates symptoms. The ICO contains 6 items that focus on the discomfort associated with the ocular surface. Each of these questions has two parts, which inquire separately the frequency and severity of the symptoms. The evaluator will deliver the questionnaire to the subject and allow the subject to answer it calmly without any pressure and / or coercion, will only assist him if he has difficulty understanding any of the questions.
Outcome measures
| Measure |
PRO-201
n=27 Participants
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
|
Value of the Ocular Comfort Index (OCI) Questionnaire.
BV OCI
|
24.93 scores on a scale
Standard Deviation 9.46
|
|
Value of the Ocular Comfort Index (OCI) Questionnaire.
FV OCI
|
25.05 scores on a scale
Standard Deviation 10.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days: 1 (Basal Visit), 7 ± 1 (Visit 1), 16 ± 1 (Final Visit)Population: Only the values obtained from the right eyes were analyzed for this variable. The evaluated population for this outcome measure was the PP population (subjects who finished the study without presenting any mayor deviations to protocol and adherence equal or higher to 90%).
It was graded according to the Sjögren's International Clinical Collaboration Alliance (SICCA) Ocular Staining Score (CTO). According to the CTO, grade 0 corresponds to the absence of punctate epithelial erosions (PEE); grade 1 is defined as the presence of 1-5 EEPs; grade 2 corresponds to 6-30 EEP; and \>30 EEP will be classified as grade 3. Additionally, one qualification point will be added if: 1) EEP is present in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches, including linear staining, are observed. A higher score is a worse outcome.
Outcome measures
| Measure |
PRO-201
n=27 Eyes (right)
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
|
Number of Cases With Corneal and Conjunctival Staining With Lissamine Green
BV Corneal and conjunctival staining with lissamine green : Grade 0
|
27 Eyes (right)
|
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Number of Cases With Corneal and Conjunctival Staining With Lissamine Green
BV Corneal and conjunctival staining with lissamine green : Grade 1
|
0 Eyes (right)
|
|
Number of Cases With Corneal and Conjunctival Staining With Lissamine Green
BV Corneal and conjunctival staining with lissamine green : Grade 2
|
0 Eyes (right)
|
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Number of Cases With Corneal and Conjunctival Staining With Lissamine Green
V1 Corneal and conjunctival staining with lissamine green : Grade 0
|
23 Eyes (right)
|
|
Number of Cases With Corneal and Conjunctival Staining With Lissamine Green
V1 Corneal and conjunctival staining with lissamine green : Grade 1
|
2 Eyes (right)
|
|
Number of Cases With Corneal and Conjunctival Staining With Lissamine Green
V1 Corneal and conjunctival staining with lissamine green : Grade 2
|
2 Eyes (right)
|
|
Number of Cases With Corneal and Conjunctival Staining With Lissamine Green
FV Corneal and conjunctival staining with lissamine green : Grade 0
|
26 Eyes (right)
|
|
Number of Cases With Corneal and Conjunctival Staining With Lissamine Green
FV Corneal and conjunctival staining with lissamine green : Grade 1
|
1 Eyes (right)
|
|
Number of Cases With Corneal and Conjunctival Staining With Lissamine Green
FV Corneal and conjunctival staining with lissamine green : Grade 2
|
0 Eyes (right)
|
Adverse Events
PRO-201
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PRO-201
n=29 participants at risk
A total of 29 anticipated healthy volunteers will be exposed to the investigation product.
Atropine Sulfate: Administration of one drop QD on both eyes for 14 days.
|
|---|---|
|
Eye disorders
Foreign body sensation
|
6.9%
2/29 • From day 1 (basal visit) to the safety call on day 21(±2 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
|
24.1%
7/29 • From day 1 (basal visit) to the safety call on day 21(±2 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
irritation in the area of instillation
|
34.5%
10/29 • From day 1 (basal visit) to the safety call on day 21(±2 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
|
31.0%
9/29 • From day 1 (basal visit) to the safety call on day 21(±2 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 hyperemia
|
13.8%
4/29 • From day 1 (basal visit) to the safety call on day 21(±2 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
Pruritus
|
10.3%
3/29 • From day 1 (basal visit) to the safety call on day 21(±2 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
|
10.3%
3/29 • From day 1 (basal visit) to the safety call on day 21(±2 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
|
6.9%
2/29 • From day 1 (basal visit) to the safety call on day 21(±2 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
decreased visual acuity
|
6.9%
2/29 • From day 1 (basal visit) to the safety call on day 21(±2 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
Restriction type: OTHER