Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Version 01 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Is the primary objective of this investigation to compare the clinical efficacy of the drug test - Ster ® (prednisolone 1% ophthalmic suspension - Union Chemicals) in the comparator - Fort ® Pred (prednisolone 1% ophthalmic suspension - Allergan) in the control of postoperative inflammation in cataract surgery by phacoemulsification through periodic measurement of efficiency scores (number of cells in the anterior chamber, the presence of fibrin in the anterior chamber, conjunctival hyperemia, corneal edema and Descemet folds).
The secondary objective is to compare the safety data observed during the study period, ie will be assessed the frequency and intensity of adverse reactions and compared statistically between groups.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Ster ® (prednisolone 1% ophthalmic suspension - União QuÃmica) |
|
| Comparator | Active Comparator | Pred Fort ® (prednisolone 1% ophthalmic suspension - Allergan) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ster | Drug | prednisolone 1% ophthalmic suspension |
| |
| Pred Fort |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of clinical efficacy between the test and comparator drugs by measuring periodic scores of efficacy in established clinical parameters. | We will evaluate the clinical parameters of number of cells in the anterior chamber, the presence of fibrin in the anterior chamber, conjunctival hyperemia, corneal edema and Descemet folds.The treatment will last for 28 days following the conduct of routine postoperative cataract. There will be a total of 04 returns after surgery and with them 07, 14, 21 and 28 days. On each return, will register the change of parameters of efficacy and safety. | 28 days of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of safety data observed during the study period by assessing frequency and intensity of adverse reactions, compared statistically between groups. | The treatment will last for 28 days following the conduct of routine postoperative cataract. There will be a total of 04 returns after surgery and with them 07, 14, 21 and 28 days. On each return, will register the change of parameters of efficacy and safety. |
Not provided
Inclusion Criteria:
Patients who agree with all study procedures and sign, by his own free will, IC;
Exclusion Criteria:
Patients with a history or clinical diagnosis of other eye diseases such as glaucoma, corneal ulcers, scarring, and uveitis;
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAL ClÃnica Pesquisa e Desenvolvimento Ltda | Valinhos | São Paulo | Brazil |
Not provided
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014260 | Triclosan |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
prednisolone 1% ophthalmic suspension |
|
| 28 days of treatment. |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |