Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery.
Status:
Completed
Trial end date:
2020-07-21
Target enrollment:
Participant gender:
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.