PRO-232 in Patients Subjected to Cataract Surgery

NCT07305987 | Recruiting Phase 3 DMC

• 1 other identifier: SOPH232-1023/III
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cataract Extraction

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with grade 0 cellularity among interventions

  Using a slit lamp, a detailed assessment of cellularity in the anterior chamber of the eye will be performed. Using a 0.5 X 8.0mm beam of light directed obliquely the degree of cellularity will be measured. The grade of cellularity in the anterior chamber will be reported acording to the following scale: Grade Number of cells Grade 0 (≤ 5 cells), grade 1+ (5-10 cells \[mild\]), grade 2+ (11-20 \[moderate\]), grade 3+ (21-50 \[marked\]), grade 4+ (over 50 \[severe\]). The evaluated population for this outcome measure will be the PP population (subjects who finished the study without presenting any mayor deviations to protocol).

  Day 1, 3, 8 and 15.

• Proportion of patients presenting unexpected adverse events (AE) related between interventions

  The manifested adverse events during the conduction of this trial will be obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These will be previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol. The classification as unexpected and/or related will be based in previously reported AE for the ingredients of the investigational products and comparators. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.

  Day 1, 3, 8, 15 and 20.

Secondary Outcomes (4)

• Degree of cellularity in the anterior chamber between interventions

  Day 1, 3, 8 and 15.

• Pain level score between interventions.

  Day 1, 3, 8 and 15.

• Changes in best corrected visual acuity (BCVA) measurement between interventions

  Day 1, 3, 8 and 15.

• Proportion of patients who present an increase in intraocular pressure (IOP) ≥10 mmHg compared to baseline.

  Day 1, 3, 8 and 15.

Study Arms (2)

PRO-232

EXPERIMENTAL

Two eyedroppers: one for PRO-232 and another for Placebo. Both will be administrated as follows: 1 drop four times a day (QID) with a minimum of four hours between applications, in the study eye for 14 days; with the exception of day 1 (the same day of the baseline visit), where a reduction in the interval between applications to a minimum of 3 hours per day will be allowed. A period of minimum 5 minutes between eyedropper administration will be required.

Drug: Moxifloxacin / Dexamethasone Ophthalmic Solution; Drug: Placebo

Moxifloxacin / Dexamethasone

ACTIVE COMPARATOR

Two eyedroppers: one for moxifloxacin and another for dexamethasone. Both will be administrated as follows: 1 drop four times a day (QID) with a minimum of four hours between applications, in the study eye for 14 days; with the exception of day 1 (the same day of the baseline visit), where a reduction in the interval between applications to a minimum of 3 hours per day will be allowed. A period of minimum 5 minutes between eyedropper administration will be required.

Drug: Moxifloxacin Hydrochloride, Ophthalmic; Drug: Dexamethasone phosphate

Interventions

Placebo DRUG

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

PRO-232

Moxifloxacin / Dexamethasone Ophthalmic Solution DRUG

Moxifloxacin 0.5% / Dexamethasone phosphate 0.1% Ophthalmic solution

Also known as: PRO-232

PRO-232

Moxifloxacin Hydrochloride, Ophthalmic DRUG

Moxifloxacin 0.5% Ophthalmic solution

Moxifloxacin / Dexamethasone

Dexamethasone phosphate DRUG

Dexamethasone phosphate 0.1% Ophthalmic solution

Moxifloxacin / Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 an intraocular pressure ≥ 8 and ≤ 21 mmHg.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (2)

Retina Center

Tijuana, Estado de Baja California, 22010, Mexico

RECRUITING

RGH Integra

Puebla City, Puebla, 72180, Mexico

RECRUITING

MeSH Terms

Interventions

Moxifloxacin; Vision, Ocular; dexamethasone 21-phosphate

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Light Signal Transduction; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Cell Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena

Central Study Contacts

Oscar Olvera-Montaño, MD

CONTACT

3330004200; oscar.olvera@sophia.com.mx

Alejandra Sánchez-Ríos, MD

CONTACT

3330004200; alejandra.sanchez@sophia.com.mx

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase III, parallel, controlled, comparative, double-blind, multicenter clinical study

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: December 26, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)