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
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®.
This is a Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial. The variables to be evaluated include:
Primary (safety):
Primary (tolerability):
Secondary (safety):
Secondary (tolerability):
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 37 is below the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Laboratorios Sophia S.A de C.V. is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Elimination Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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
* 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®
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)
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)
| Milestone | PRO-231 | VIGAMOXI® |
|---|---|---|
| Started | 18 | 19 |
| Completed | 18 | 19 |
| Not completed | 0 | 0 |
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.
| number of related adverse events | PRO-231 | VIGAMOXI® |
|---|---|---|
| Incidence of Unexpected Adverse Events Related to the Interventions | 1 | 4 |
Any signs of conjunctival hyperemia in between interventions.
| number of patients | PRO-231 | VIGAMOXI® |
|---|---|---|
| Day 0 (Basal Visit) | 5 | 4 |
| Day 3 (Visit 1) | 3 | 4 |
| Day 8 (Final Visit) | 4 | 3 |
The BCVA will be evaluated through Snellen chart.
| 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 |
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.
| Participants | PRO-231 | VIGAMOXI® |
|---|---|---|
| Days 0 (Basal Visit) | 0 | 0 |
| Days 3 (Visit 1) | 0 | 1 |
| Day 8 (Final Visit) | 0 | 0 |
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.
| 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 |
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.
| number of unexpected adverse events | PRO-231 | VIGAMOXI® |
|---|---|---|
| Incidence of Unexpected Adverse Events (Excluding Conjunctival Hyperemia and Chemosis) | 1 | 4 |
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.
| 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 |
Collected over Day 1 (Start of product application) to Day 12 (safety call). Non-serious events are listed at a 0% frequency threshold.
| 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%) |
| 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 |
| 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(years) | PRO-231 | VIGAMOXI® | Total |
|---|---|---|---|
| Mean | 23.55 ± 4.89 | 25.79 ± 6.21 | 24.76 ± 5.69 |
| Sex: Female, Male(Participants) | PRO-231 | VIGAMOXI® | Total |
|---|---|---|---|
| Female | 6 | 11 | 17 |
| Male | 12 | 8 | 20 |
| Race/Ethnicity, Customized(Participants) | PRO-231 | VIGAMOXI® | Total |
|---|---|---|---|
| Hispanic | 18 | 19 | 37 |
| Region of Enrollment(Participants) | PRO-231 | VIGAMOXI® | Total |
|---|---|---|---|
| Mexico | 18 | 19 | 37 |
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Studies of the drug tested here: Moxifloxacin
Laboratorios Sophia S.A de C.V. →