Actively Recruiting
PRO-232 in Patients Subjected to Cataract Surgery
Led by Laboratorios Sophia S.A de C.V. · Updated on 2025-12-26
134
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PRO-232 in Patients Subjected to Cataract Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to voluntarily provide signed informed consent
- Willing and able to attend scheduled visits and follow study procedures
- Age 18 years or older
- Male or female
- Women of childbearing age must use hormonal contraceptives or an intrauterine device during the study
- Postoperative diagnosis of uncomplicated cataract extraction by phacoemulsification with intraocular lens placement within one day before inclusion
- Eye pressure between 8 and 21 mmHg
You will not qualify if you...
- Allergy to any components of the study drugs or testing compounds
- Surgery on both eyes during the same surgical period
- Surgery not performed within 24 hours before inclusion
- Iridectomy or injury to the pupillary sphincter during surgery
- Use of eye drops between surgery and baseline visit
- History of glaucoma or ocular hypertension
- History of chronic or recurrent inflammatory eye disease or eye pain prior to surgery
- Presence of corneal abrasion or ulcer
- Use of topical, subconjunctival, systemic steroids, or anti-inflammatory drugs within specified timeframes
- Use of blood thinners, systemic steroids, or immunomodulators in the past two weeks
- Periocular steroid injections within specified timeframes
- Suspected or confirmed eye infections such as keratitis, conjunctivitis, or endophthalmitis
- Severe corneal swelling preventing evaluation
- Conditions requiring steroid use other than topical eye application
- Single functional eye
- Participation in any clinical trial within 30 days prior
- Previous participation in this study
- Active inflammatory or infectious disease at study entry
- Unresolved eye injuries or trauma
- Use of antibacterial, antiviral, or antifungal agents within 30 days prior or during study
- Use of pilocarpine or prostaglandin analogues
- Secondary implantation or replacement of intraocular lens in study eye
- Pregnant, breastfeeding, or planning pregnancy during study
- Immediate family members employed by the research site or sponsor involved in the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Retina Center
Tijuana, Estado de Baja California, Mexico, 22010
Actively Recruiting
2
RGH Integra
Puebla City, Puebla, Mexico, 72180
Actively Recruiting
Research Team
O
Oscar Olvera-Montaño, MD
CONTACT
A
Alejandra Sánchez-Ríos, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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