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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Difluprednate Ophthalmic Emulsion 0.05% |
|
| Comparator | Active Comparator | Prednisolone Acetate 1% - Phenylephrine 0.12% Ophthalmic Suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Difluprednate Ophthalmic Emulsion 0.05% | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to visit 3 (96 hours from surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Thickness | Retinal Thickness measured by Optical Coherence Tomography (mm) | Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28) |
| Corneal endothelial cell count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Tosi, M.D. | Laboratorios Poen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorios Poen | Ciudad Autonoma de Buenos Aire | Buenos Aires F.D. | C1407BDR | Argentina |
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|
| Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution | Drug | 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. |
|
Corneal endothelial cell count measured by specular microscope (cells/mm2)
| 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) | 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) | 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) | 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 | 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) | Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28). |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C109237 | OmpF protein |
| C009935 | prednisolone acetate |
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