Clinical trial NCT04631315: Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Laboratorios Poen
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change from baseline corneal thickness between treatments
timeFrame: Baseline to visit 3 (96 hours from surgery)
Secondary outcomes:
measure: Retinal Thickness
timeFrame: Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28)
measure: Corneal endothelial cell count
timeFrame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
measure: Visual acuity
timeFrame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
measure: Flare and cell on anterior chamber
timeFrame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
measure: Intraocular pressure
timeFrame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
measure: Equal safety profile of both treatments
timeFrame: Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28)
measure: Corneal Thickness by pachymetry
timeFrame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Laboratorios Poen
state: Ciudad Autonoma De Buenos Aires
Study officials:
affiliation: Laboratorios Poen
name: Jorge Tosi, M.D.
role: STUDY_DIRECTOR
References: