MedTrace Logo

PRO-232 in Patients Subjected to Cataract Surgery

NCT07305987 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-12-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2026-06-30
Completion
2026-07-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07305987 on ClinicalTrials.gov