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

Laboratorios Poen

Status and phase

Completed

Phase 4

Conditions

Cataract

Treatments

Drug: Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution

Drug: Difluprednate Ophthalmic Emulsion 0.05%

Study type

Interventional

Funder types

Industry

Identifiers

NCT04631315

DIFLUPRED03

Details and patient eligibility

About

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.

Enrollment

255 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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