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HealthyPhase 1PRO-232NCT06352541

Study Evaluating PRO-232 an Ophthalmic Solution Compared to Placebo.

A Phase 1 study testing PRO-232 in people with Healthy, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase I study evaluating safety and tolerability through the incidence of unexpected adverse events and IOP measurement, as well as through the incidence of stinging after its administration, compared to placebo. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PRO-232
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteMexico
Study dates
8 Feb 2024to 28 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Investigacion e Innovacion en Medicina Traslacional

    Mexico City

Other trials in Mexico

About this study

Official title: Phase I Clinical Study, Evaluating Safety and Tolerability of PRO-232 an Ophthalmic Solution, Versus Placebo, When Applied to the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers.

This is a phase I study evaluating safety and tolerability through the incidence of unexpected adverse events and IOP measurement, as well as through the incidence of stinging after its administration, compared to placebo.

Read the detailed description

The variables to be evaluated include:

Primary (safety):

  • Unexpected adverse events
  • IOP

Primary (tolerability):

  • Stinging

Secondary (safety):

  • Expected and related adverse events
  • BCVA
  • Ocular surface stining

Secondary (tolerability):

  • Other ocular symptoms (foreign body sensation and tearing)

The operational definition states a difference under 15% in order to consider non inferior the safety and tolerability profile of PRO-232 compared to placebo.

Conditions
Healthy
Being tested
PRO-232, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRO-232Drug

    Moxifloxacin 0.5% and Dexamethasone Phosphate 0.1%

  • PlaceboOther

    Vehicle Control, ophthalmic solution

Study groups in NCT06352541
Study groupRoleWhat they receive
PRO-232Experimental* PRO-232. Moxifloxacin 0.5% y Dexamethasone Phosphate 0.1% Ophthalmic solution. * Dosage: 1 drop QID [4] (four times per day) for 7 days on right eye.
Receives: Drug: PRO-232
PlaceboPlacebo comparator* Placebo. Sodium Chloride. * Dosage: 1 drop QID [4] (four times per day) for 7 days on right eye.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence Unexpected Related Adverse Reactions

    Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention.

    Measured: Days 0 (Basal Visit) 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)

  2. Changes in intraocular pressure (IOP)

    Previous instillation of topical anesthetic, the IOP (right eye) will be measured through a Goldmann tonometer during visits

    Measured: Days 0 (Basal Visit) 3 (Visit 1), 8 (Final Visit)

  3. Incidence of Stinging

    The subjects will be questioned regarding this symptom's incidence (right eye), frecuency, duration and severity will not be considered, only its incidence will.

    Measured: Days 0 (Basal Visit, 3 (Visit 1) and 8 (Final Visit)

Secondary outcomes (4)

  1. Incidence of Expected Related Adverse Events

    Incidence of expexted related adverse events according to those previously described in bibliography: itching, blurry vision, eyelid pain, conjunctival hyperemia, ocular hypertension.

    Measured: Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)

  2. Changes in Best Corrected Visual Acuity (BCVA)

    BCVA will be evaluated through Snellen chart

    Measured: Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)

  3. Changes in the integrity of the ocular surface (fluorescein staining)

    Changes in the integrity of the ocular surface using fluorescein staining and evaluated through the Oxford scale. 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)

  4. Incidence of ocular symptoms (foreign body sensation and tearing)

    The subjects will be questioned regarding this symptoms' incidence.

    Measured: Days 0 (Basal Visit), 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.

  1. First posted8 Apr 2024
  2. Study start8 Feb 2024
  3. Primary completion28 May 2024
  4. Study completion28 May 2024

Resources

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 groups, double blind, one center.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06352541
Sponsor's protocol ID
SOPH232-0824/I
Acronym
PRO-232
Status last verified
Apr 2026
First submitted
2 Apr 2024
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PRO-232 in people with Healthy, 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 16 Apr 2026. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Unexpected Related Adverse Reactions (time frame: Days 0 (Basal Visit) 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06352541.

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 16 Apr 2026.

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PRO-232 Clinical Trial NCT06352541 | AzTrials