Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery.
- Conditions
- Cataract
- Interventions
- Registration Number
- NCT04631315
- Lead Sponsor
- Laboratorios Poen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Difluprednate Ophthalmic Emulsion 0.05% Difluprednate Ophthalmic Emulsion 0.05% Comparator Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution Prednisolone Acetate 1% - Phenylephrine 0.12% Ophthalmic Suspension
- Primary Outcome Measures
Name Time Method Change from baseline corneal thickness between treatments Baseline to visit 3 (96 hours from surgery) 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.
- Secondary Outcome Measures
Name Time Method Visual acuity Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28). Visual acuity measured by visual acuity standardized chart (20/20)
Equal safety profile of both treatments Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28) Report of adverse events of both treatments under study
Flare and cell on anterior chamber Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28). Presence of flare and cells on anterior chamber using slit lamp (biomicroscopy)
Intraocular pressure Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28). Intraocular pressure measured by Goldmann tonometer (mmHg)
Corneal endothelial cell count Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28). Corneal endothelial cell count measured by specular microscope (cells/mm2)
Corneal Thickness by pachymetry Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28). Corneal Thickness (mm)
Retinal Thickness Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28) Retinal Thickness measured by Optical Coherence Tomography (mm)
Trial Locations
- Locations (1)
Laboratorios Poen
🇦🇷Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina