NCT07305987

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, randomized, double-blind, parallel-group, controlled clinical study designed to evaluate the efficacy and safety of PRO-232 ophthalmic solution in postoperative cataract patients. Participants will receive study treatment for 14 days. The primary efficacy endpoint is to evaluate PRO-232 ophthalmic solution applied to the ocular surface of postoperative cataract patients, compared with concomitant administration of ophthalmic moxifloxacin and dexamethasone, by the proportion of patients with a grade 0 cellularity after 14 days of treatment. Secondary outcomes include assessment of anterior chamber cellularity, ocular inflammation, eye pain using the Wong-Baker Faces® Visual Analog Scale, incidence of treatment-releated unexpected adverse events, best-corrected visual acuity (BCVA), and changes in intraocular pressure (IOP).

Conditions

• Cataract Extraction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-27
• Primary completion: 2026-06-30
• Completion: 2026-07-30
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

2 sites across 1 country: Mexico