Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery.

• Status: Completed
• Trial end date: 2020-07-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Poen
• Treatments: Difluprednate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Ophthalmic Solutions; Oxymetazoline; Phenylephrine; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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