PRO-232 eye drops for use after 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.

This trial will test whether PRO-232 eye drops given for 14 days after uncomplicated cataract surgery work as well as or better than standard moxifloxacin plus dexamethasone drops in adults.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Laboratorios Sophia S.A de C.V. (Industry-sponsored)
• Locations: 2 sites (Tijuana, Estado de Baja California and 1 other locations)
• Trial ID: NCT07305987 on ClinicalTrials.gov

What this trial studies

This Phase 3, multicenter, randomized, double-blind, parallel-group controlled study compares PRO-232 ophthalmic solution with concomitant ophthalmic moxifloxacin and dexamethasone in adults after uncomplicated phacoemulsification. Participants are randomized to receive study treatment for 14 days with follow-up to measure clinical response and safety. The primary endpoint is the proportion of patients with grade 0 anterior chamber cellularity at day 14, and secondary outcomes include ocular inflammation scores, eye pain (Wong-Baker Faces), best-corrected visual acuity, intraocular pressure changes, and incidence of adverse events. The study is conducted at sites in Tijuana and Puebla, Mexico.

Who should consider this trial

Good fit: Adults aged 18 or older who had uncomplicated unilateral cataract extraction by phacoemulsification with intraocular lens placement within one day, have intraocular pressure between 8 and 21 mmHg, can consent, and can attend scheduled visits are ideal candidates.

Not a fit: Patients with complicated cataract surgery, bilateral procedures, significant ocular comorbidities, uncontrolled intraocular pressure, or who cannot comply with visits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, PRO-232 could simplify postoperative eye care by combining anti-inflammatory and antimicrobial effects in a single formulation and potentially improve recovery after cataract surgery.

How similar studies have performed: Antibiotic-plus-steroid topical regimens are commonly used and have established benefits after cataract surgery, but PRO-232 itself is a relatively novel formulation now being tested in a phase 3 comparison.

Eligibility criteria

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.

Where this trial is running

Tijuana, Estado de Baja California and 1 other locations

• Retina Center — Tijuana, Estado de Baja California, Mexico (Recruiting)
• RGH Integra — Puebla City, Puebla, Mexico (Recruiting)

Study contacts

• Study coordinator: Oscar Olvera-Montaño, MD

Conditions Cataract Extraction