Efficacy and Safety of Difluprednate Ophthalmic Emulsion vs. a Fixed-Combination of Prednisolone Acetate - Phenylephrine Ophthalmic Suspension on Post-operative Inflammation Following Cataract Surgery.

DIFLUPRED03

This controlled, randomized, double blind, multicenter study will be carried out to demonstrate that the topical ophthalmic nanoemulsion of difluprednate 0.05% (Tolf®, Poen Laboratories), has a high anti-inflammatory efficacy, which would allow it to be administered after cataract surgery 1 drop, twice a day , starting the day before surgery and continuing for 14 days and 1 drop, once a day for the following 2 weeks, achieving an adequate anti-inflammatory activity, with the benefit of reducing the toxicity on the ocular surface, improving the dosage and adherence to treatment. The follow-up time will be 28 days and the outcome measures will be evaluated in a baseline (time 0), on day 1, on day 4 and on day 28 after surgery. The active control will be prednisolone acetate 1% + phenylephrine hydrochloride 0.12% topical ophthalmic suspension (Prednefrin® Forte, Allergan Argentina) given 1 drop, 4 times a days and 1 drop, twice a day for the next 2 weeks. Corneal thickness, central macula thickness, endothelial cell count, intraocular pressure, visual acuity, anterior chamber clearance and lacrimal film recovery will be evaluated.

2019-03-24

2020-05-24

2020-07-21

Completed

Early phase I

255

Inclusion Criteria: * Patients of both sexes between 45 and 65 years old (women who are not fertile) who undergo cataract surgery N2 and N3, defined according to BCN10, Decimal classification of cataracts. * That the surgical technique is ultrasonic phacoemulsification. * Patients who have an initial corneal thickness between 500 and 570 µm inclusive. * Patients with initial intraocular pressure between 12 and 18 mm Hg inclusive. * Patients with an endothelial cell count greater than 1000 cells / mm2 Exclusion Criteria: * Patients who use eye medication, except eye lubricant. * Patients who before surgery have not been able to dilate their pupil more than 5 mm * Patients who have been treated with corticosteroids or systemic anti-inflammatory drugs for 2 weeks prior to enrollment * Patients who have received periocular corticosteroid injections in the study eye within the previous 4 weeks or used depot corticosteroids within 2 months prior to enrollment * Patients who have received a topical ocular corticosteroid or non-steroidal anti-inflammatory drug (NSAID) within 24 hours prior to enrollment * History of glaucoma or ocular hypertension in the study eye, history or presence of endogenous uveitis, or corneal abrasion or ulceration * Patients with a diagnosis or suspicion of keratoconjunctival disease caused by viruses, bacteria, or fungi * Patients which presents an allergy to the drug to be tested or to any similar drug such as other corticosteroids * History of increased intraocular pressure due to the use of corticosteroids * Patients with pathological macular features * Diabetics * Breastfeeding women * Patients with rheumatoid arthritis. * Patients treated with Amiodarone

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2023-05-12