Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification
Condition: Cataract
MeSH terms: Cataract; Inflammation
Intervention: Difluprednate 0.05%; Prednefrin
Intervention description: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.; 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.
- Route of administration: topical ophthalmic
Intervention MeSH terms: Fluprednisolone; Difluprednate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind, controlled, parallel group, multicentre, randomized
Masking: Double (Participant, Investigator)
Masking description: Blinding and masking The blinding will correspond to the research subject and the principal investigator. In addition, the statistical analysis will be carried out in a blinded manner in the case of a partial and final analysis.
The masking will be carried out using boxes in the identical primary packaging in the two groups and re-labeling the bottles of both interventions.
Blinding for the research subject and the researcher will be done by replacing the commercial labels in the case of the comparator in the bottles and the use of identical labels that contain the assignment number.
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: corticosteroid; anti-inflammatory steroid; phacoemulsification

Summary:

      objective: To evaluate the efficacy of the ophthalmic emulsion PRO-145 in the treatment of
      inflammation and pain after phacoemulsification.

      Hypothesis:

      The use of the ophthalmic emulsion PRO-145 is effective in decreasing the inflammatory
      response evaluated by means of cellularity in the anterior chamber, after
      phacoemulsification.

      Methodology:

      Phase III clinical trial, double-blind, controlled, parallel group, multicentre, randomized.

      Number of patients:

      178 subjects divided into 2 groups (89 subjects per group), who will provide an eye for the
      evaluation of efficacy.

      Diagnosis and main inclusion criteria:

      Diagnosis: Postoperative phacoemulsification and foldable intraocular lens placement in a
      bag.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent.

          -  Age ≥ 18 years.

          -  Both sexes.

          -  Postoperative cataract surgery by phacoemulsification. o That they have met the
             criteria for phacoemulsification and a classification of the lens opacity
             classification system (LOCS) III cataract of Opalescence of the nucleus (NO) ≥2 and
             Kernel color (NC) ≥2.

        Exclusion Criteria:

          -  Pregnant women, lactating or planning to get pregnant.

          -  Women of reproductive age and who do not have a hormonal contraceptive method,
             intrauterine device or bilateral tubal obstruction.

          -  Participation in another clinical research study ≤ 30 days before the baseline visit.

          -  Have previously participated in this same study with the contralateral eye.

          -  That they can not comply with their attendance at appointments or with all the
             requirements of the protocol.

        Medical and therapeutic criteria.

          -  Surgery in both eyes in the same surgical shift.

          -  Time> 24 hours after having surgery.

          -  Intraocular lens placement outside the bag.

          -  Presentation of rupture of the posterior capsule, with or without the presence of
             vitreous.

          -  Carrying out an iridectomy, or lesion of the pupillary sphincter during
             phacoemulsification surgery.

          -  Scheduled for surgical intervention in the contralateral eye during the study period.

          -  History of glaucoma or ocular hypertension.

          -  History of increased Intraocular pressure (IOP) with the use of steroids.

          -  Intraocular pressure (IOP) ≥24.

          -  History of uveitis.

          -  Presence of corneal abrasion or corneal ulceration in the study eye.

          -  Use of steroids or topical non steroidal anti inflammatory drugs, 24 hours prior to
             surgery and until the start of instillation of investigational drugs.

          -  Use of anticoagulants, systemic steroids or immunomodulators in the last two weeks

          -  Periocular injection of any steroid in the study eye 4 weeks before the start of the
             instillation of the investigational drugs.

          -  Use of storage steroids 2 months prior to the start of instillation of investigational
             drugs.

          -  Presence or suspicion of keratitis and / or viral, bacterial or fungal conjunctivitis.

          -  Presence or suspicion of endophthalmitis.

          -  Presence or suspicion of toxic syndrome of the anterior segment.

          -  Severe corneal edema that does not allow assessment of the anterior chamber

          -  Macular diseases.

          -  Diabetes Mellitus with glycosylated hemoglobin (A1C) ≥ 6.5% (48 mmol / mol) or fasting
             glucose (no caloric intake by ≥ 8 hours) of ≥ 126 mg / dL (7.0 mmol / L).

          -  Any disease or condition that requires the use of topical or systemic nonsteroidal
             anti-inflammatories (NSAIDs) during the time of intervention.

          -  Any disease or condition that requires the use of steroids other than topical
             ophthalmic application.

          -  Subjects with a single eye.

          -  Any condition or disease that at the discretion of the principal investigator (IP)
             does not make the subject suitable for the study.

          -  Known hypersensitivity to the components of the products under investigation.