PRO-232 in Patients Subjected to Cataract Surgery

Laboratorios Sophia

Status and phase: Enrolling; Phase 3

Conditions: Cataract Extraction

Treatments: Drug: Dexamethasone phosphate; Drug: Placebo; Drug: Moxifloxacin / Dexamethasone Ophthalmic Solution; Drug: Moxifloxacin Hydrochloride, Ophthalmic

Study type: Interventional

Funder types: Industry

Identifiers

NCT07305987

SOPH232-1023/III

Details and patient eligibility

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.

Full 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).

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups

PRO-232

Experimental group

Description:

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.

Treatment:

Drug: Moxifloxacin / Dexamethasone Ophthalmic Solution

Drug: Placebo

Moxifloxacin / Dexamethasone

Active Comparator group

Description:

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.

Treatment:

Drug: Moxifloxacin Hydrochloride, Ophthalmic

Drug: Dexamethasone phosphate