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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
255
1 drop, 2 times a day, starting the day before surgery and continuing for 14 post-surgical days and 1 drop, once a day for the next 2 weeks.
1 drop, 4 times a day, starting the day before surgery and continuing for 14 post-surgical days and 1 drop, twice a day for the next 2 weeks.
Laboratorios Poen
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Change from baseline corneal thickness between treatments
Demonstrate that 0.05% difluprednate ophthalmic nanoemulsion administered 1 drop, 2 times a day, beginning the day before cataract surgery and continuing for the first 14 postoperative days and then 1 drop, once a day for the next 14 days, it does not present an anti-inflammatory efficacy lower than treatment with prednisolone acetate 1% + phenylephrine hydrochloride 0.12% ophthalmic suspension administered 1 drop, 4 times a day starting the day before surgery and continuing during the first 14 post-surgical days and 1 drop , 2 times a day for the next 14 days, for the treatment of postsurgical inflammation, in patients operated on for N2 and N3 cataracts. Difluprednate 0.05% ophthalmic nanoemulsion will not be clinically inferior than Prednisolone acetate 1% + 0.12% phenylephrine hydrochloride ophthalmic suspension, if the difference in corneal thickness obtained with OCT between the baseline day and the post-surgical day it does not differ beyond 17 µm between treatments.
Time frame: Baseline to visit 3 (96 hours from surgery)
Retinal Thickness
Retinal Thickness measured by Optical Coherence Tomography (mm)
Time frame: Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28)
Corneal endothelial cell count
Corneal endothelial cell count measured by specular microscope (cells/mm2)
Time frame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
Visual acuity
Visual acuity measured by visual acuity standardized chart (20/20)
Time frame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
Flare and cell on anterior chamber
Presence of flare and cells on anterior chamber using slit lamp (biomicroscopy)
Time frame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
Intraocular pressure
Intraocular pressure measured by Goldmann tonometer (mmHg)
Time frame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
Equal safety profile of both treatments
Report of adverse events of both treatments under study
Time frame: Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28)
Corneal Thickness by pachymetry
Corneal Thickness (mm)
Time frame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
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