Ophthalmological Agent ToxicityPhase 1NCT06363292
Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects
A Phase 1 study testing PRO-231 and VIGAMOXI® in people with Ophthalmological Agent Toxicity and Bacterial Conjunctivitis, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ophthalmological Agent Toxicity, Bacterial Conjunctivitis
- What is being tested?
- PRO-231 and VIGAMOXI®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteMexico
- Study dates
- 30 Jan 2024to 28 May 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
IIMET Investigación e Innovación en Medicina Traslacional
Guadalajara, Jalisco, 44610
About this study
Official title: Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects.
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).
- Being tested
- PRO-231, VIGAMOXI®
- Medical subject headings
- Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-231Drug
Also called Moxifloxacin
Moxifloxacin 0.5% Ophthalmic solution.
VIGAMOXI®Drug
Also called Moxifloxacin
Moxifloxacin 0.5% Ophthalmic solution.
| Study group | Role | What they receive |
|---|---|---|
| PRO-231 | Experimental | * 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. Receives: Drug: PRO-231 |
| VIGAMOXI® | Active comparator | * 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. Receives: Drug: VIGAMOXI® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 0 (Basal Visit), and 8 (Final Visit)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Days 3 (Visit 1), 8 (Final Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start30 Jan 2024
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ophthalmological Agent ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alejandra Sanchez-Rios, MD, Study director, Regional Medical Affairs Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363292
- Sponsor's protocol ID
- SOPH231-1221/I
- Status last verified
- Jun 2025
- First submitted
- 9 Apr 2024
- Last updated
- 15 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects.
- ClinicalTrials.gov ID
- NCT06363292
- Acronym / sponsor ID
- SOPH231-1221/I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Posted 15 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| PRO-231 | Experimental | Drug: 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. |
| VIGAMOXI® | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO-231Also: MoxifloxacinMoxifloxacin 0.5% Ophthalmic solution. | Drug | PRO-231 |
| VIGAMOXI®Also: MoxifloxacinMoxifloxacin 0.5% Ophthalmic solution. | Drug | VIGAMOXI® |
Primary outcome
Incidence of Unexpected Adverse Events Related to the Interventions
Time frame: 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.
Incidence of Conjunctival Hyperemia
Time frame: Days 0 (Basal Visit), 3 (Visit 1), and 8 (Final Visit)
Any signs of conjunctival hyperemia in between interventions.
Changes in Best Corrected Visual Acuity (BCVA)
Time frame: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)
The BCVA will be evaluated through Snellen chart.
Number of Patients With Any Changes in Grade Measurement of the Integrity of the Ocular Surface (Fluorescein Staining)
Time frame: 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.
Changes in the Ocular Comfort Index (OCI) Score Between Interventions.
Time frame: 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.
2 secondary outcomes
Incidence of Unexpected Adverse Events (Excluding Conjunctival Hyperemia and Chemosis)
Time frame: Days 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)
To Assess the Tolerability of PRO-231 Ophthalmic Solution
Time frame: Days 3 (Visit 1), 8 (Final Visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandra Sanchez-Rios, MD study director
Regional Medical Affairs Manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRO-231 and VIGAMOXI® in people with Ophthalmological Agent Toxicity and Bacterial Conjunctivitis, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Unexpected Adverse Events Related to the Interventions (time frame: Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.