Trial Outcomes & Findings for Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects (NCT NCT06363292)
NCT ID: NCT06363292
Last Updated: 2025-06-15
Results Overview
Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention. Adverse events where inquired and evaluated in every time point specified in the time frame, however, the final number of adverse events reported throught the entire study was evaluated for each group.
COMPLETED
PHASE1
37 participants
Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)
2025-06-15
Participant Flow
Participant milestones
| Measure |
PRO-231
* PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
|
VIGAMOXI®
* VIGAMOXI® :Moxifloxacin 0.5% Ophthalmic Solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
VIGAMOXI®: Moxifloxacin 0.5% Ophthalmic solution.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects
Baseline characteristics by cohort
| Measure |
PRO-231
n=18 Participants
* PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
|
VIGAMOXI®
n=19 Participants
* VIGAMOXI® :Moxifloxacin 0.5% Ophthalmic Solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
VIGAMOXI®: Moxifloxacin 0.5% Ophthalmic solution.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23.55 years
STANDARD_DEVIATION 4.89 • n=5 Participants
|
25.79 years
STANDARD_DEVIATION 6.21 • n=7 Participants
|
24.76 years
STANDARD_DEVIATION 5.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention. Adverse events where inquired and evaluated in every time point specified in the time frame, however, the final number of adverse events reported throught the entire study was evaluated for each group.
Outcome measures
| Measure |
PRO-231
n=18 Participants
* PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
|
VIGAMOXI®
n=19 Participants
* VIGAMOXI® :Moxifloxacin 0.5% Ophthalmic Solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
VIGAMOXI®: Moxifloxacin 0.5% Ophthalmic solution.
|
|---|---|---|
|
Incidence of Unexpected Adverse Events Related to the Interventions
|
1 number of related adverse events
|
4 number of related adverse events
|
PRIMARY outcome
Timeframe: Days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit)Any signs of conjunctival hyperemia in between interventions.
Outcome measures
| Measure |
PRO-231
n=18 Participants
* PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
|
VIGAMOXI®
n=19 Participants
* VIGAMOXI® :Moxifloxacin 0.5% Ophthalmic Solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
VIGAMOXI®: Moxifloxacin 0.5% Ophthalmic solution.
|
|---|---|---|
|
Incidence of Conjunctival Hyperemia
Day 0 (Basal Visit)
|
5 number of patients
|
4 number of patients
|
|
Incidence of Conjunctival Hyperemia
Day 3 (Visit 1)
|
3 number of patients
|
4 number of patients
|
|
Incidence of Conjunctival Hyperemia
Day 8 (Final Visit)
|
4 number of patients
|
3 number of patients
|
PRIMARY outcome
Timeframe: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)The BCVA will be evaluated through Snellen chart.
Outcome measures
| Measure |
PRO-231
n=18 Participants
* PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
|
VIGAMOXI®
n=19 Participants
* VIGAMOXI® :Moxifloxacin 0.5% Ophthalmic Solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
VIGAMOXI®: Moxifloxacin 0.5% Ophthalmic solution.
|
|---|---|---|
|
Changes in Best Corrected Visual Acuity (BCVA)
Day 3 (Visit 1)
|
-0.02 Best Corrected Visual Acuity (LogMar)
Standard Deviation 0.05
|
-0.03 Best Corrected Visual Acuity (LogMar)
Standard Deviation 0.05
|
|
Changes in Best Corrected Visual Acuity (BCVA)
Day 8 (Final Visit)
|
-0.04 Best Corrected Visual Acuity (LogMar)
Standard Deviation 0.06
|
-0.03 Best Corrected Visual Acuity (LogMar)
Standard Deviation 0.07
|
|
Changes in Best Corrected Visual Acuity (BCVA)
Day 0 (Basal Visit)
|
-0.03 Best Corrected Visual Acuity (LogMar)
Standard Deviation 0.06
|
-0.02 Best Corrected Visual Acuity (LogMar)
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)Number of patients with any changes in the integrity of the ocular surface using fluorescein staining and evaluated through the Oxford scale compared to baseline. The standard Oxford scale for fluorescein staining has the following criteria: Grade 0- Equal to or less than panel A; Grade I- Equal to or less than panel B, greater than panel A; Grade II- Equal to or less than panel C, greater than panel B; Grade III- Equal or less than panel D, greater than panel C; Grade IV- Equal or less than panel E, greater than panel D; Grade V- Greater than panel E.
Outcome measures
| Measure |
PRO-231
n=18 Participants
* PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
|
VIGAMOXI®
n=19 Participants
* VIGAMOXI® :Moxifloxacin 0.5% Ophthalmic Solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
VIGAMOXI®: Moxifloxacin 0.5% Ophthalmic solution.
|
|---|---|---|
|
Number of Patients With Any Changes in Grade Measurement of the Integrity of the Ocular Surface (Fluorescein Staining)
Days 0 (Basal Visit)
|
0 Participants
|
0 Participants
|
|
Number of Patients With Any Changes in Grade Measurement of the Integrity of the Ocular Surface (Fluorescein Staining)
Days 3 (Visit 1)
|
0 Participants
|
1 Participants
|
|
Number of Patients With Any Changes in Grade Measurement of the Integrity of the Ocular Surface (Fluorescein Staining)
Day 8 (Final Visit)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 0 (Basal Visit), and 8 (Final Visit)The Ocular Comfort Index is a questionnaire designed to measure ocular surface irritation. It assesses symptoms related to comfort in cases of ocular surface disorders. The Ocular Comfort Index is composed of 12 items that assess the frequency and intensity symptoms. Each item is scored on a scale from 0 to 6 (never to always, or absent to severe). The total score becomes a linear continuous interval scale, which ranges from 0 (least symptomatic) to 100 (most symptomatic). The questionnaire was administered to each research subject, allowing them to respond calmly without any pressure and/or coercion. The results were collected using the Ocular Comfort Index calculator \[1\], obtaining a logit score and a 0-100 scale score for each subject. \[1\].- M. E. Johnson, "Measurement of Ocular Surface Irritation on a Linear Interval Scale with the Ocular Comfort Index," Investigative Ophthalmology \& Visual Science, vol. 48, nº 10, 2007.
Outcome measures
| Measure |
PRO-231
n=18 Participants
* PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
|
VIGAMOXI®
n=19 Participants
* VIGAMOXI® :Moxifloxacin 0.5% Ophthalmic Solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
VIGAMOXI®: Moxifloxacin 0.5% Ophthalmic solution.
|
|---|---|---|
|
Changes in the Ocular Comfort Index (OCI) Score Between Interventions.
Day 0 (Basal Visit)
|
25.91 score on a scale
Standard Deviation 8.17
|
28.01 score on a scale
Standard Deviation 8.60
|
|
Changes in the Ocular Comfort Index (OCI) Score Between Interventions.
Day 8 (Final Visit)
|
19.78 score on a scale
Standard Deviation 11.86
|
27.14 score on a scale
Standard Deviation 10.22
|
SECONDARY outcome
Timeframe: Days 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention, excluding conjunctival hyperemia and chemosis. Unexpected adverse events where inquired and evaluated in every time point specified in the time frame, however, the final number of adverse events reported throught the entire study was evaluated for each group.
Outcome measures
| Measure |
PRO-231
n=18 Participants
* PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
|
VIGAMOXI®
n=19 Participants
* VIGAMOXI® :Moxifloxacin 0.5% Ophthalmic Solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
VIGAMOXI®: Moxifloxacin 0.5% Ophthalmic solution.
|
|---|---|---|
|
Incidence of Unexpected Adverse Events (Excluding Conjunctival Hyperemia and Chemosis)
|
1 number of unexpected adverse events
|
4 number of unexpected adverse events
|
SECONDARY outcome
Timeframe: Days 3 (Visit 1), 8 (Final Visit)To assess the tolerability of PRO-231 ophthalmic solution applied to the ocular surface, in healthy volunteers, versus VIGAMOXI®, by means of: Presence of ocular symptoms (burning, foreign body sensation, pruritus and lacrimation) between interventions.
Outcome measures
| Measure |
PRO-231
n=18 Participants
* PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
|
VIGAMOXI®
n=19 Participants
* VIGAMOXI® :Moxifloxacin 0.5% Ophthalmic Solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
VIGAMOXI®: Moxifloxacin 0.5% Ophthalmic solution.
|
|---|---|---|
|
To Assess the Tolerability of PRO-231 Ophthalmic Solution
Pruitus Day 8 (Final Visit)
|
2 ocular symptom events
|
2 ocular symptom events
|
|
To Assess the Tolerability of PRO-231 Ophthalmic Solution
Burning Day 0 (Basal Visit)
|
0 ocular symptom events
|
0 ocular symptom events
|
|
To Assess the Tolerability of PRO-231 Ophthalmic Solution
Burning Day 3 (Visit 1)
|
4 ocular symptom events
|
5 ocular symptom events
|
|
To Assess the Tolerability of PRO-231 Ophthalmic Solution
Burning Day 8 (Final Visit)
|
3 ocular symptom events
|
2 ocular symptom events
|
|
To Assess the Tolerability of PRO-231 Ophthalmic Solution
Foreign Body Sensation Day 0 (Basal Visit)
|
0 ocular symptom events
|
0 ocular symptom events
|
|
To Assess the Tolerability of PRO-231 Ophthalmic Solution
Foreign Body Sensation Day 3 (Visit 1)
|
1 ocular symptom events
|
0 ocular symptom events
|
|
To Assess the Tolerability of PRO-231 Ophthalmic Solution
Foreign Body Sensation Day 8 (Final Visit)
|
1 ocular symptom events
|
0 ocular symptom events
|
|
To Assess the Tolerability of PRO-231 Ophthalmic Solution
Pruritus Day 0 (Basal Visit)
|
0 ocular symptom events
|
0 ocular symptom events
|
|
To Assess the Tolerability of PRO-231 Ophthalmic Solution
Pruritus Day 3 (Visit 1)
|
3 ocular symptom events
|
2 ocular symptom events
|
|
To Assess the Tolerability of PRO-231 Ophthalmic Solution
Lacrimation Day 0 (Basal Visit)
|
0 ocular symptom events
|
0 ocular symptom events
|
|
To Assess the Tolerability of PRO-231 Ophthalmic Solution
Lacrimation Day 3 (Visit 1)
|
0 ocular symptom events
|
0 ocular symptom events
|
|
To Assess the Tolerability of PRO-231 Ophthalmic Solution
Lacrimation Day 8 (Final Visit)
|
0 ocular symptom events
|
0 ocular symptom events
|
Adverse Events
PRO-231
VIGAMOXI®
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PRO-231
n=18 participants at risk
* PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
PRO-231: Moxifloxacin 0.5% Ophthalmic solution.
|
VIGAMOXI®
n=19 participants at risk
* VIGAMOXI® :Moxifloxacin 0.5% Ophthalmic Solution.
* Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye).
* Route of administration: Topical ophthalmic.
VIGAMOXI®: Moxifloxacin 0.5% Ophthalmic solution.
|
|---|---|---|
|
Eye disorders
Patient-reported conjunctival redness
|
11.1%
2/18 • Number of events 2 • Day 1 (Start of product application) to Day 12 (safety call)
|
21.1%
4/19 • Number of events 4 • Day 1 (Start of product application) to Day 12 (safety call)
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • Day 1 (Start of product application) to Day 12 (safety call)
|
10.5%
2/19 • Number of events 2 • Day 1 (Start of product application) to Day 12 (safety call)
|
|
Eye disorders
Dry eye sensation
|
0.00%
0/18 • Day 1 (Start of product application) to Day 12 (safety call)
|
5.3%
1/19 • Number of events 1 • Day 1 (Start of product application) to Day 12 (safety call)
|
|
Eye disorders
Blurred vision
|
0.00%
0/18 • Day 1 (Start of product application) to Day 12 (safety call)
|
5.3%
1/19 • Number of events 1 • Day 1 (Start of product application) to Day 12 (safety call)
|
|
Eye disorders
Heaviness sensation (eyelids)
|
0.00%
0/18 • Day 1 (Start of product application) to Day 12 (safety call)
|
5.3%
1/19 • Number of events 1 • Day 1 (Start of product application) to Day 12 (safety call)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place