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PRO-232 in Patients Subjected to Cataract Surgery | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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.

NCT07305987•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.

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 a postoperative diagnosis (unilateral, single eye) of cataract extraction by phacoemulsification with uncomplicated intraocular lens (IOL) placement\*\* on the day prior to inclusion.
•Having an intraocular pressure ≥ 8 and ≤ 21 mmHg.
•* A complicated cataract surgery will be defined by study, as any procedure where the planned surgical technique has been modified or the use of vitrectomy has been required, an IOL has not been placed, a different IOL from the originally planned model has been placed or an IOL has been placed outside the capsular bag, remains of the lens have been left inside the eye, there was rupture of the posterior capsule with or without the presence of vitreous, or detachment of Descemet's membrane occured, there was disinsertion of the capsular pouch, or there was trauma to the iris or ciliary body during the surgical procedure. In the event of any other situation that could be considered a complication and that is not reflected in this list, the inclusion of said patient will be at the discretion of the researcher.

Exclusion Criteria

•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.
•Not having had surgery within a period of 24 hours before inclusion.
•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.
+18 more criteria

Locations (2)

Retina Center

Tijuana, Estado de Baja California, Mexico

RGH Integra

Puebla City, Puebla, Mexico

Key Dates

Start Date

October 27, 2025

Primary Completion Date

June 30, 2026

Completion Date

July 30, 2026

Last Updated

December 26, 2025

Enrollment

134

ESTIMATED participants

Conditions

Cataract Extraction

Interventions

Moxifloxacin / Dexamethasone Ophthalmic Solution

DRUG

Placebo

DRUG

Moxifloxacin Hydrochloride, Ophthalmic

DRUG

Dexamethasone phosphate

DRUG

Contacts

Oscar Olvera-Montaño, MD

CONTACT

3330004200 oscar.olvera@sophia.com.mx

Alejandra Sánchez-Ríos, MD

CONTACT

3330004200 alejandra.sanchez@sophia.com.mx

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PRO-232 in Patients Subjected to Cataract Surgery

Inclusion Criteria

Exclusion Criteria

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