CompletedNCT06363292Updated Jun 15, 2025Results posted

Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects

A Phase 1 interventional study of PRO-231 and VIGAMOXI® in Ophthalmological Agent Toxicity and Bacterial Conjunctivitis, sponsored by Laboratorios Sophia S.A de C.V.. Completed at 1 site in Mexico. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-15.

Sponsored by Laboratorios Sophia S.A de C.V. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 37
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study summary

This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, compared to VIGAMOXI®.

Read the detailed description

This is a Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial. The variables to be evaluated include:

Primary (safety):

Incidence of unexpected adverse events related to the interventions
Incidence of conjunctival hyperemia and chemosis
Changes in Best Corrected Visual Acuity (BCVA) assessed with Snellen chart
Changes in ocular surface integrity using fluorescein staining, using the standard Oxford scale.

Primary (tolerability):

Changes in the ocular comfort index (OCI) score

Secondary (safety):

Incidence of unexpected adverse events related to the interventions(excluding conjunctival hyperemia and/or chemosis).

Secondary (tolerability):

Presence of other ocular symptoms (burning, foreign body sensation, pruritus and lacrimation).

Conditions studied

Ophthalmological Agent Toxicity
Bacterial Conjunctivitis

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Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Having the ability to voluntarily give their signed informed consent.
Ophthalmologically and clinically healthy subjects.
Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.
Age between 18 to 45 years.
Male or female gender.
Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO [Tubal Ligation]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the informed consent form [ICF]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.
Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.
Corneal staining ≤ grade I on the Oxford Scale.
Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.

Exclusion criteria

Exclusion Criteria:

History of hypersensitivity to fluoroquinolones, steroid anti-inflammatories, or any of the components of the drugs under investigation.
Use of ophthalmic medications from any pharmacological group.
Use of medications by any other route of administration.
Use of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, or antibiotics by any route of administration in the last 30 days.
History of eye surgery in the last 6 months.
Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.
In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.
Having participated in any clinical research study 30 days prior to inclusion in this study.
Having previously participated in this same study.
History of any chronic-degenerative disease, including Diabetes Mellitus or Systemic Arterial Hypertension.
Diagnosis of glaucoma or ocular hypertension.
Known diagnosis of liver or heart disease.
Presenting active inflammatory or infectious disease at the time of entry into the study.
Presenting unresolved lesions or traumas at the time of entry into the study.
Having been subjected to non-ophthalmological surgical procedures in the last 3 months.
Being or having an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an employee of the research site or the sponsor, and who directly participates in this study.
Active smoking (specified as the consumption of cigarettes regardless of the amount and frequency, 4 weeks prior to study inclusion and during the intervention period of this study).
Active alcoholism (specified as the consumption of alcoholic beverages, regardless of the amount and frequency, 72 hours prior to study inclusion and during the intervention period of this study).

Elimination Criteria

Withdrawal of their consent to participate in the study (informed consent form).
Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and/or the sponsor, could affect the patient's fitness to safely continue with the study procedures.
Non-tolerability or hypersensitivity to any of the compounds used during the tests -(fluorescein, tetracaine).
Non-tolerability or hypersensitivity to any of the drugs under investigation.
Adherence \< 80% determined by the subject's diary and corroborated by the final weight of the research products (RP) compared to the initial weight.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 37 participants (actual)

Study arms

Experimental
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.
Drug: PRO-231
Active comparator
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.
Drug: VIGAMOXI®

Interventions

DrugPRO-231
Moxifloxacin 0.5% Ophthalmic solution.
Also known as: Moxifloxacin
DrugVIGAMOXI®
Moxifloxacin 0.5% Ophthalmic solution.
Also known as: Moxifloxacin

What researchers measure

Primary outcomes

Incidence of Unexpected Adverse Events Related to the Interventions
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.
Time frame: Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)
Incidence of Conjunctival Hyperemia
Any signs of conjunctival hyperemia in between interventions.
Time frame: Days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit)
Changes in Best Corrected Visual Acuity (BCVA)
The BCVA will be evaluated through Snellen chart.
Time frame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Number of Patients With Any Changes in Grade Measurement of the Integrity of the Ocular Surface (Fluorescein Staining)
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.
Time frame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Changes in the Ocular Comfort Index (OCI) Score Between Interventions.
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.
Time frame: Days 0 (Basal Visit), and 8 (Final Visit)

Secondary outcomes

Incidence of Unexpected Adverse Events (Excluding Conjunctival Hyperemia and Chemosis)
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.
Time frame: Days 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)
To Assess the Tolerability of PRO-231 Ophthalmic Solution
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.
Time frame: Days 3 (Visit 1), 8 (Final Visit)

Results

Posted Jun 15, 2025

Participant flow

Participant flow — Overall Study
Milestone	PRO-231	VIGAMOXI®
Started	18	19
Completed	18	19
Not completed	0	0

Outcome measures

PrimaryIncidence of Unexpected Adverse Events Related to the Interventions

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.

Time frame:: Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)
Reported as:: Number · number of related adverse events

Incidence of Unexpected Adverse Events Related to the Interventions
number of related adverse events	PRO-231	VIGAMOXI®
Incidence of Unexpected Adverse Events Related to the Interventions	1	4

PrimaryIncidence of Conjunctival Hyperemia

Any signs of conjunctival hyperemia in between interventions.

Time frame:: Days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit)
Reported as:: Number · number of patients

Incidence of Conjunctival Hyperemia
number of patients	PRO-231	VIGAMOXI®
Day 0 (Basal Visit)	5	4
Day 3 (Visit 1)	3	4
Day 8 (Final Visit)	4	3

PrimaryChanges in Best Corrected Visual Acuity (BCVA)

The BCVA will be evaluated through Snellen chart.

Time frame:: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Reported as:: Mean · Best Corrected Visual Acuity (LogMar)

Changes in Best Corrected Visual Acuity (BCVA)
Best Corrected Visual Acuity (LogMar)	PRO-231	VIGAMOXI®
Day 0 (Basal Visit)	-0.03 ± 0.06	-0.02 ± 0.07
Day 3 (Visit 1)	-0.02 ± 0.05	-0.03 ± 0.05
Day 8 (Final Visit)	-0.04 ± 0.06	-0.03 ± 0.07

PrimaryNumber of Patients With Any Changes in Grade Measurement of the Integrity of the Ocular Surface (Fluorescein Staining)

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.

Time frame:: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
Reported as:: Count of participants · Participants

Number of Patients With Any Changes in Grade Measurement of the Integrity of the Ocular Surface (Fluorescein Staining)
Participants	PRO-231	VIGAMOXI®
Days 0 (Basal Visit)	0	0
Days 3 (Visit 1)	0	1
Day 8 (Final Visit)	0	0

PrimaryChanges in the Ocular Comfort Index (OCI) Score Between Interventions.

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.

Time frame:: Days 0 (Basal Visit), and 8 (Final Visit)
Reported as:: Mean · score on a scale

Changes in the Ocular Comfort Index (OCI) Score Between Interventions.
score on a scale	PRO-231	VIGAMOXI®
Day 0 (Basal Visit)	25.91 ± 8.17	28.01 ± 8.60
Day 8 (Final Visit)	19.78 ± 11.86	27.14 ± 10.22

SecondaryIncidence of Unexpected Adverse Events (Excluding Conjunctival Hyperemia and Chemosis)

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.

Time frame:: Days 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)
Reported as:: Number · number of unexpected adverse events

Incidence of Unexpected Adverse Events (Excluding Conjunctival Hyperemia and Chemosis)
number of unexpected adverse events	PRO-231	VIGAMOXI®
Incidence of Unexpected Adverse Events (Excluding Conjunctival Hyperemia and Chemosis)	1	4

SecondaryTo Assess the Tolerability of PRO-231 Ophthalmic Solution

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.

Time frame:: Days 3 (Visit 1), 8 (Final Visit)
Reported as:: Number · ocular symptom events

To Assess the Tolerability of PRO-231 Ophthalmic Solution
ocular symptom events	PRO-231	VIGAMOXI®
Burning Day 0 (Basal Visit)	0	0
Burning Day 3 (Visit 1)	4	5
Burning Day 8 (Final Visit)	3	2
Foreign Body Sensation Day 0 (Basal Visit)	0	0
Foreign Body Sensation Day 3 (Visit 1)	1	0
Foreign Body Sensation Day 8 (Final Visit)	1	0
Pruritus Day 0 (Basal Visit)	0	0
Pruritus Day 3 (Visit 1)	3	2
Pruitus Day 8 (Final Visit)	2	2
Lacrimation Day 0 (Basal Visit)	0	0
Lacrimation Day 3 (Visit 1)	0	0
Lacrimation Day 8 (Final Visit)	0	0

Adverse events

Collected over Day 1 (Start of product application) to Day 12 (safety call). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
PRO-231	0/18 (0%)	0/18 (0%)	3/18 (16.7%)
VIGAMOXI®	0/19 (0%)	0/19 (0%)	9/19 (47.4%)

Most frequent other events

Most frequent other events
Event	PRO-231	VIGAMOXI®
Patient-reported conjunctival rednessEye disorders	2/18	4/19
HeadacheNervous system disorders	1/18	2/19
Dry eye sensationEye disorders	0/18	1/19
Blurred visionEye disorders	0/18	1/19
Heaviness sensation (eyelids)Eye disorders	0/18	1/19

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	PRO-231	VIGAMOXI®	Total
<=18 years	0	0	0
Between 18 and 65 years	18	19	37
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	PRO-231	VIGAMOXI®	Total
Mean	23.55 ± 4.89	25.79 ± 6.21	24.76 ± 5.69

Sex: Female, Male
Sex: Female, Male(Participants)	PRO-231	VIGAMOXI®	Total
Female	6	11	17
Male	12	8	20

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	PRO-231	VIGAMOXI®	Total
Hispanic	18	19	37

Region of Enrollment
Region of Enrollment(Participants)	PRO-231	VIGAMOXI®	Total
Mexico	18	19	37

Study locations

1 site

IIMET Investigación e Innovación en Medicina Traslacional
Guadalajara, Jalisco 44610, Mexico

References and documents

Study documents

Protocol and statistical analysis plan · Jul 27, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT06363292
Lead sponsor: Laboratorios Sophia S.A de C.V.
Responsible party: Sponsor
First posted: Apr 12, 2024
Start date: Jan 30, 2024
Primary completion: May 28, 2024
Completion: May 28, 2024
Results posted: Jun 15, 2025
Last update: Jun 15, 2025

Study contacts

Alejandra Sanchez-Rios, MD

study director · Regional Medical Affairs Manager

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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