Cataract ExtractionPhase 3PRO-232NCT07305987
PRO-232 in Patients Subjected to Cataract Surgery
A Phase 3 study testing Moxifloxacin / Dexamethasone Ophthalmic Solution, Moxifloxacin Hydrochloride, Ophthalmic and Dexamethasone phosphate in people with Cataract Extraction, run by Laboratorios Sophia S.A de C.V. at 2 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Extraction
- What is being tested?
- Moxifloxacin / Dexamethasone Ophthalmic Solution, Moxifloxacin Hydrochloride, Ophthalmic and Dexamethasone phosphate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 2 sitesMexico
- Study dates
- 27 Oct 2025to 30 Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 28Show fewer
- 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.
- Use of blood thinners, systemic steroids, or immunomodulators within the past two weeks.
- Periocular injection of any steroid 4 weeks prior to initiation of investigational drug instillation or depot steroid use 2 months prior to initiation of investigational drug instillation.
- Presence or suspicion of viral, bacterial or fungal keratitis and/or conjunctivitis.
- Presence or suspicion of endophthalmitis.
- Presence or suspicion of anterior segment toxic syndrome.
- Severe corneal edema that does not allow the evaluation of the anterior chamber.
- Any disease or condition that requires the use of steroids by any route other than topical ophthalmic application.
- Patients with a single functional eye.
- Any condition or disease that, in the opinion of the main investigator, does not make the patient suitable for the study.
- Having participated in any investigational clinical study 30 days prior to inclusion in this study.
- Having previously participated in this same study.
- Having an active inflammatory or infectious disease at the time of study entry.
- Having unresolved eye injuries or trauma at the time of study entry.
- Use of antibacterial, antiviral, or antifungal agents by any route of administration within 30 days prior to study enrollment (including intracameral transsurgical antibiotics or administered to irrigation solution), or during the study.
- Use of pilocarpine and prostaglandin analogues.
- Secondary implantation or replacement of the intraocular lens (IOL) in the study eye.
- For women: being pregnant, breastfeeding, or planning to become pregnant within the study period.
- Be or have an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is employed by the research site or sponsor, and who is directly involved in this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico2 sites, 2 recruiting
- Recruiting
RGH Integra
Puebla City, Puebla, 72180
- Recruiting
Retina Center
Tijuana, Estado de Baja California, 22010
About this study
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.
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.
Read the 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
- Being tested
- Moxifloxacin / Dexamethasone Ophthalmic Solution, Placebo, Moxifloxacin Hydrochloride, Ophthalmic, Dexamethasone phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin / Dexamethasone Ophthalmic SolutionDrug
Also called PRO-232
Moxifloxacin 0.5% / Dexamethasone phosphate 0.1% Ophthalmic solution
PlaceboDrug
Same excipients as PRO-232, without active principles (moxifloxacin and dexamethasone)
Moxifloxacin Hydrochloride, OphthalmicDrug
Moxifloxacin 0.5% Ophthalmic solution
Dexamethasone phosphateDrug
Dexamethasone phosphate 0.1% Ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| PRO-232 | Experimental | 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. Receives: Drug: Moxifloxacin / Dexamethasone Ophthalmic Solution; Drug: Placebo |
| Moxifloxacin / Dexamethasone | Active comparator | 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. Receives: Drug: Moxifloxacin Hydrochloride, Ophthalmic; Drug: Dexamethasone phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Day 1, 3, 8, 15 and 20.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1, 3, 8 and 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start27 Oct 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, parallel, controlled, comparative, double-blind, multicenter clinical study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305987
- Sponsor's protocol ID
- SOPH232-1023/III
- Acronym
- PRO-232
- Status last verified
- Dec 2025
- First submitted
- 30 Jul 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07305987
- Acronym / sponsor ID
- PRO-232 / SOPH232-1023/III
- Conditions
- Cataract Extraction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase III, parallel, controlled, comparative, double-blind, multicenter clinical study
| Arm | Type | Receives |
|---|---|---|
| PRO-232 | Experimental | Drug: Moxifloxacin / Dexamethasone Ophthalmic Solution, Drug: PlaceboTwo 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. |
| Moxifloxacin / Dexamethasone | Active comparator | Drug: Moxifloxacin Hydrochloride, Ophthalmic, Drug: Dexamethasone phosphateTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxifloxacin / Dexamethasone Ophthalmic SolutionAlso: PRO-232Moxifloxacin 0.5% / Dexamethasone phosphate 0.1% Ophthalmic solution | Drug | PRO-232 |
| PlaceboSame excipients as PRO-232, without active principles (moxifloxacin and dexamethasone) | Drug | PRO-232 |
| Moxifloxacin Hydrochloride, OphthalmicMoxifloxacin 0.5% Ophthalmic solution | Drug | Moxifloxacin / Dexamethasone |
| Dexamethasone phosphateDexamethasone phosphate 0.1% Ophthalmic solution | Drug | Moxifloxacin / Dexamethasone |
Primary outcome
Proportion of patients with grade 0 cellularity among interventions
Time frame: Day 1, 3, 8 and 15.
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).
Proportion of patients presenting unexpected adverse events (AE) related between interventions
Time frame: Day 1, 3, 8, 15 and 20.
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.
4 secondary outcomes
Degree of cellularity in the anterior chamber between interventions
Time frame: Day 1, 3, 8 and 15.
Pain level score between interventions.
Time frame: Day 1, 3, 8 and 15.
Changes in best corrected visual acuity (BCVA) measurement between interventions
Time frame: Day 1, 3, 8 and 15.
Proportion of patients who present an increase in intraocular pressure (IOP) ≥10 mmHg compared to baseline.
Time frame: Day 1, 3, 8 and 15.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moxifloxacin / Dexamethasone Ophthalmic Solution, Moxifloxacin Hydrochloride, Ophthalmic and Dexamethasone phosphate in people with Cataract Extraction, run by Laboratorios Sophia S.A de C.V. at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oscar Olvera-Montaño, MD (3330004200, oscar.olvera@sophia.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with grade 0 cellularity among interventions (time frame: Day 1, 3, 8 and 15.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.