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RECRUITING
NCT07305987
PHASE3

PRO-232 in Patients Subjected to Cataract Surgery

Sponsor: Laboratorios Sophia S.A de C.V.

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2025-10-27

Completion Date

2026-07-30

Last Updated

2025-12-26

Healthy Volunteers

No

Interventions

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)

Retina Center

Tijuana, Estado de Baja California, Mexico

RGH Integra

Puebla City, Puebla, Mexico