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

Cataract Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cataract
• Inflammation

• NCT number: NCT04631315
• Study type: Interventional
• Source: Laboratorios Poen
• Status: Completed
• Phase: Phase 4
• Start date: March 24, 2019
• Completion date: July 21, 2020