A Phase 3 interventional study of Moxifloxacin / Dexamethasone Ophthalmic Solution and Placebo in Cataract Extraction, sponsored by Laboratorios Sophia S.A de C.V.. Recruiting at 2 sites in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Laboratorios Sophia S.A de C.V. · Phase 3, Interventional, and Treatment
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.
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).
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 134 is above the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Laboratorios Sophia S.A de C.V. is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
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Having an intraocular pressure ≥ 8 and ≤ 21 mmHg.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two eyedroppers: one for PRO-232 and another for Placebo. Both will be administrated as follows: 1 drop four times a day (QID) with a minimum of four hours between applications, in the study eye for 14 days; with the exception of day 1 (the same day of the baseline visit), where a reduction in the interval between applications to a minimum of 3 hours per day will be allowed. A period of minimum 5 minutes between eyedropper administration will be required.
Drug: Moxifloxacin / Dexamethasone Ophthalmic Solution · Drug: Placebo
Two eyedroppers: one for moxifloxacin and another for dexamethasone. Both will be administrated as follows: 1 drop four times a day (QID) with a minimum of four hours between applications, in the study eye for 14 days; with the exception of day 1 (the same day of the baseline visit), where a reduction in the interval between applications to a minimum of 3 hours per day will be allowed. A period of minimum 5 minutes between eyedropper administration will be required.
Drug: Moxifloxacin Hydrochloride, Ophthalmic · Drug: Dexamethasone phosphate
Drug pages: Moxifloxacin · Dexamethasone
Moxifloxacin 0.5% / Dexamethasone phosphate 0.1% Ophthalmic solution
Also known as: PRO-232
Same excipients as PRO-232, without active principles (moxifloxacin and dexamethasone)
Drug page: Moxifloxacin
Moxifloxacin 0.5% Ophthalmic solution
Dexamethasone phosphate 0.1% Ophthalmic solution
Proportion of patients with grade 0 cellularity among interventions
Using a slit lamp, a detailed assessment of cellularity in the anterior chamber of the eye will be performed. Using a 0.5 X 8.0mm beam of light directed obliquely the degree of cellularity will be measured. The grade of cellularity in the anterior chamber will be reported acording to the following scale: Grade Number of cells Grade 0 (≤ 5 cells), grade 1+ (5-10 cells \[mild\]), grade 2+ (11-20 \[moderate\]), grade 3+ (21-50 \[marked\]), grade 4+ (over 50 \[severe\]). The evaluated population for this outcome measure will be the PP population (subjects who finished the study without presenting any mayor deviations to protocol).
Time frame: Day 1, 3, 8 and 15.
Proportion of patients presenting unexpected adverse events (AE) related between interventions
The manifested adverse events during the conduction of this trial will be obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These will be previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol. The classification as unexpected and/or related will be based in previously reported AE for the ingredients of the investigational products and comparators. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.
Time frame: Day 1, 3, 8, 15 and 20.
Degree of cellularity in the anterior chamber between interventions
Using a slit lamp, a detailed assessment of cellularity in the anterior chamber of the eye will be performed. Using a 0.5 X 8.0mm beam of light directed obliquely the degree of cellularity will be measured. The grade of cellularity in the anterior chamber will be reported acording to the following scale: Grade Number of cells Grade 0 (≤ 5 cells), grade 1+ (5-10 cells \[mild\]), grade 2+ (11-20 \[moderate\]), grade 3+ (21-50 \[marked\]), grade 4+ (over 50 \[severe\]). A higher score is a worse outcome. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.
Time frame: Day 1, 3, 8 and 15.
Pain level score between interventions.
The patient's level of eye pain will be assessed using a visual analog scale (Wong-Baker FACES® Visual Analog Scale). The scoring system will be as follows: Severity: (0) Doesn't hurt, (2) Hurts a little, (4) Hurts a little more, (6) Hurts a lot, (8) Hurts too much, (10) Unbearable pain. A higher score is a worse outcome. This outcome measure considered the Intention-To-Treat (ITT) population, all participants who were randomized and exposed to treatment, regardless of whether they finished the study.
Time frame: Day 1, 3, 8 and 15.
Changes in best corrected visual acuity (BCVA) measurement between interventions
The patient will be evaluated using his/her best refractive correction. BCVA is a test of visual function. It will be evaluated with the Snellen chart. The Snellen chart is the standard tool used to evaluate visual acuity. It was located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.This score can be expressed in fraction (i.e. 20/20) decimal (i.e. 1.0), or LogMAR (i.e. 0) formats. In this study, BCVA wiil be expressed in fraction and LogMAR formats. In fraction format and in LogMAR, a higher denominator number or number (respectively) is a worse outcome.
Time frame: Day 1, 3, 8 and 15.
Proportion of patients who present an increase in intraocular pressure (IOP) ≥10 mmHg compared to baseline.
The IOP will be measured through Goldmann tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP will be evaluated. Normal values are considered between 10 and 21 mmHg.
Time frame: Day 1, 3, 8 and 15.
Plan to share: No
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Studies of the drugs tested here: Moxifloxacin · Dexamethasone
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