PRO-232 in Patients Subjected to Cataract Surgery

Phase III Clinical Study, to Evaluate the Efficacy and Safety of PRO-232 Ophthalmic Solution on the Ocular Surface of Patients Postoperative to Cataract Surgery by Phacoemulsification.

PRO-232 in Patients Subjected to Cataract Surgery (NCT07305987) is a Phase 3 interventional studying Cataract Extraction, sponsored by Laboratorios Sophia S.A de C.V.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Cataract Extraction, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 134 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Cataract Extraction subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - To have the ability to voluntarily grant their signed willing to sign a consent form (FCI). - Being able and willing to comply with scheduled visits in the treatment plan and other study procedures. - Being 18 years of age or older. - Male or female. - Women within childbearing age who do not have a history of bilateral tubaric obstruction, hysterectomy, or bilateral oophorectomy should ensure continued use (initiated ≥ 30 days prior to signing the ICF) of a hormonal contraceptive method or intrauterine device (IUD) during the study period. - Having a postoperative diagnosis (unilateral, single eye) of cataract extraction by phacoemulsification with uncomplicated intraocular lens (IOL) placement\*\* on the day prior to inclusion. - Having an intraocular pressure ≥ 8 and ≤ 21 mmHg. - A complicated cataract surgery will be defined by study, as any procedure where the planned surgical technique has been modified or the use of vitrectomy has been required, an IOL has not been placed, a different IOL from the originally planned model has been placed or an IOL has been placed outside the capsular bag, remains of the lens have been left inside the eye, there was rupture of the posterior capsule with or without the presence of vitreous, or detachment of Descemet's membrane occured, there was disinsertion of the capsular pouch, or there was trauma to the iris or ciliary body during the surgical procedure. In the event of any other situation that could be considered a complication and that is not reflected in this list, the inclusion of said patient will be at the discretion of the researcher. Who Should NOT Join This Trial: - Allergy to any of the components of the investigational products or to any of the compounds used during testing. - Surgery on both eyes during the same surgical period. - Not having had surgery within a period of 24 hours before inclusion. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * To have the ability to voluntarily grant their signed informed consent (FCI). * Being able and willing to comply with scheduled visits in the treatment plan and other study procedures. * Being 18 years of age or older. * Male or female. * Women within childbearing age who do not have a history of bilateral tubaric obstruction, hysterectomy, or bilateral oophorectomy should ensure continued use (initiated ≥ 30 days prior to signing the ICF) of a hormonal contraceptive method or intrauterine device (IUD) during the study period. * Having a postoperative diagnosis (unilateral, single eye) of cataract extraction by phacoemulsification with uncomplicated intraocular lens (IOL) placement\*\* on the day prior to inclusion. * Having an intraocular pressure ≥ 8 and ≤ 21 mmHg. * A complicated cataract surgery will be defined by study, as any procedure where the planned surgical technique has been modified or the use of vitrectomy has been required, an IOL has not been placed, a different IOL from the originally planned model has been placed or an IOL has been placed outside the capsular bag, remains of the lens have been left inside the eye, there was rupture of the posterior capsule with or without the presence of vitreous, or detachment of Descemet's membrane occured, there was disinsertion of the capsular pouch, or there was trauma to the iris or ciliary body during the surgical procedure. In the event of any other situation that could be considered a complication and that is not reflected in this list, the inclusion of said patient will be at the discretion of the researcher. Exclusion Criteria: * Allergy to any of the components of the investigational products or to any of the compounds used during testing. * Surgery on both eyes during the same surgical period. * Not having had surgery within a period of 24 hours before inclusion. * Performing iridectomy, or injury to the pupillary sphincter during phacoemulsification surgery. * History of use of eye drops between the end of surgery and the baseline visit. * History of diagnosis of glaucoma or ocular hypertension. * History of chronic or recurrent inflammatory eye disease (uveitis, iritis, iridocyclitis, etc.), eye inflammation or pain in the eye of study prior to surgery. * Presence of corneal abrasion or ulceration. * Use of topical or subconjunctival steroids or nonsteroidal anti-inflammatory drugs (NSAIDs), 24 hours prior to surgery and until the start of instillation of investigational medications. * Use of steroids or systemic anti-inflammatory drugs within 14 days prior to surgery or if you plan to use them during the study period, or the presence of a diagnosis requiring the use of these medications during the study period. * Use of blood thinners, systemic steroids, or immunomodulators within the past two weeks. * Periocular injection of any steroid 4 weeks prior to initiation of investigational drug instillation or depot steroid use 2 months prior to initiation of investigational drug instillation. * Presence or suspicion of viral, bacterial or fungal keratitis and/or conjunctivitis. * Presence or suspicion of endophthalmitis. * Presence or suspicion of anterior segment toxic syndrome. * Severe corneal edema that does not allow the evaluation of the anterior chamber. * Any disease or condition that requires the use of steroids by any route other than topical ophthalmic application. * Patients with a single functional eye. * Any condition or disease that, in the opinion of the main investigator, does not make the patient suitable for the study. * Having participated in any investigational clinical study 30 days prior to inclusion in this study. * Having previously participated in this same study. * Having an active inflammatory or infectious disease at the time of study entry. * Having unresolved eye injuries or trauma at the time of study entry. * Use of antibacterial, antiviral, or antifungal agents by any route of administration within 30 days prior to study enrollment (including intracameral transsurgical antibiotics or administered to irrigation solution), or during the study. * Use of pilocarpine and prostaglandin analogues. * Secondary implantation or replacement of the intraocular lens (IOL) in the study eye. * For women: being pregnant, breastfeeding, or planning to become pregnant within the study period. * Be or have an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is employed by the research site or sponsor, and who is directly involved in this study.

Treatments Being Tested

DRUG

Moxifloxacin / Dexamethasone Ophthalmic Solution

Moxifloxacin 0.5% / Dexamethasone phosphate 0.1% Ophthalmic solution

DRUG

Placebo

Same excipients as PRO-232, without active principles (moxifloxacin and dexamethasone)

DRUG

Moxifloxacin Hydrochloride, Ophthalmic

Moxifloxacin 0.5% Ophthalmic solution

DRUG

Dexamethasone phosphate

Dexamethasone phosphate 0.1% Ophthalmic solution

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Retina Center

Tijuana, Estado de Baja California, Mexico

RGH Integra

Puebla City, Puebla, Mexico

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07305987), the sponsor (Laboratorios Sophia S.A de C.V.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07305987 clinical trial studying?

The main objective of this study is to evaluate the efficacy and safety of the PRO-232 formulation manufactured by Laboratorios Sophia S.A. de C.V. on the ocular surface of postoperative cataract patients versus a concomitant administration of ophthalmic moxifloxacin and dexamethasone. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07305987?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07305987?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07305987. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07305987. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.