PRO-232 in Patients Subjected to Cataract Surgery

Официальное название

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.

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат Moxifloxacin / Dexamethasone Ophthalmic Solution
  Moxifloxacin 0.5% / Dexamethasone phosphate 0.1% Ophthalmic solution
• Препарат Placebo
  Same excipients as PRO-232, without active principles (moxifloxacin and dexamethasone)
• Препарат Moxifloxacin Hydrochloride, Ophthalmic
  Moxifloxacin 0.5% Ophthalmic solution
• Препарат Dexamethasone phosphate
  Dexamethasone phosphate 0.1% Ophthalmic solution

Первичные конечные точки

• Proportion of patients with grade 0 cellularity among interventions [Срок оценки: Day 1, 3, 8 and 15.]
• Proportion of patients presenting unexpected adverse events (AE) related between interventions [Срок оценки: Day 1, 3, 8, 15 and 20.]

Вторичные конечные точки (4)

• Degree of cellularity in the anterior chamber between interventions [Срок оценки: Day 1, 3, 8 and 15.]
• Pain level score between interventions. [Срок оценки: Day 1, 3, 8 and 15.]
• Changes in best corrected visual acuity (BCVA) measurement between interventions [Срок оценки: Day 1, 3, 8 and 15.]
• Proportion of patients who present an increase in intraocular pressure (IOP) ≥10 mmHg compared to baseline. [Срок оценки: Day 1, 3, 8 and 15.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Мексика · 2 центра

• Retina Center — Tijuana
• RGH Integra — Puebla City

Идентификаторы

NCT: NCT07305987 · SOPH232-1023/III

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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