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New combo eye drop could simplify Post-Cataract care

NCT ID NCT07305987

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests a new eye drop called PRO-232, which combines an antibiotic (moxifloxacin) and a steroid (dexamethasone) in one bottle. It aims to see if this single drop works as well as using two separate drops to prevent infection and control inflammation after cataract surgery. The study will enroll 134 adults and measure how well the eye heals and any side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PRO-232 (moxifloxacin and dexamethasone) ophthalmic solution
What this could lead to
If it works, this could offer a simpler, single-bottle eye drop to prevent infection and control inflammation after cataract surgery, replacing the need for two separate drops.
What could go wrong
This is a Phase 3 trial, but it's relatively small (134 people) and compares to existing treatments, so any advantage may be modest. Side effects from the antibiotics or steroids are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 134 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • RGH Integra

    RECRUITING

    Puebla City, Puebla, 72180, Mexico

  • Retina Center

    RECRUITING

    Tijuana, Estado de Baja California, 22010, Mexico

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