RecruitingPhase 3NCT07305987

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.

Sponsor

Laboratorios Sophia S.A de C.V.

Enrollment

134 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Cataract Extraction

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dexamethasone phosphate, a drug called Moxifloxacin / Dexamethasone Ophthalmic Solution, and others for people with cataract extraction. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMoxifloxacin / Dexamethasone Ophthalmic Solution

Moxifloxacin 0.5% / Dexamethasone phosphate 0.1% Ophthalmic solution

DRUGPlacebo

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

DRUGMoxifloxacin Hydrochloride, Ophthalmic

Moxifloxacin 0.5% Ophthalmic solution

DRUGDexamethasone phosphate

Dexamethasone phosphate 0.1% Ophthalmic solution

Locations(2)

Retina Center

Tijuana, Estado de Baja California, Mexico

RGH Integra

Puebla City, Puebla, Mexico

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NCT07305987