PRO-232 in Patients Subjected to Cataract Surgery

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.
• •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.