Cataract
Conditions
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.
Interventions
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.
DRUGPrednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution
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.
Sponsors
Laboratorios Poen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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 |
| 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) |
| 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) |
Countries
Argentina
Outcome results
None listed