Back to resultsClinical Efficacy of the Drug Ster® Compared With Predfort® in Control of Postoperative Inflammation in Cataract Surgery
Primary Purpose
Inflammation, Cataract Surgery
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Ster
Pred Fort
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation focused on measuring PREUNI0710, cataract
Eligibility Criteria
Inclusion Criteria:
Patients who agree with all study procedures and sign, by his own free will, IC;
- Adult patients, regardless of gender, ethnicity or social status, with good mental health;
- Patients who present at screening visit, a clinical diagnosis of cataract with an indication for corrective surgery with phacoemulsification technique.
Exclusion Criteria:
Patients with a history or clinical diagnosis of other eye diseases such as glaucoma, corneal ulcers, scarring, and uveitis;
- Patients with known hypersensitivity to any component of the drug under investigation;
- Patients who have made use of systemic corticosteroids within 15 days before surgery;
- Patients who have made use of topical corticosteroids in the 7 days before surgery;
- Patients who have made use of systemic antibiotics in the 15 days preceding surgery;
- Patients who have made use of topical antibiotics in the 7 days before surgery;
- Patients presenting abnormality, at the discretion of the principal investigator in the following ophthalmic examinations Preoperative slit-lamp examination, measurement of intraocular pressure (applanation tonometry) and examination of background, other than the underlying disease (cataract);
- Pregnant or lactating women.
Sites / Locations
- LAL Clínica Pesquisa e Desenvolvimento Ltda
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test
Comparator
Arm Description
Ster ® (prednisolone 1% ophthalmic suspension - União Química)
Pred Fort ® (prednisolone 1% ophthalmic suspension - Allergan)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01227876
Brief Title
Clinical Efficacy of the Drug Ster® Compared With Predfort® in Control of Postoperative Inflammation in Cataract Surgery
Official Title
Assessment of Clinical Efficacy of 1% Prednisolone Acetate (Ster ®), Produced by união química, Compared to 1% Prednisolone Acetate (Pred ® Fort), Produced by Allergan, in the Control of Postoperative Inflammation in Cataract Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azidus Brasil
4. Oversight
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Cataract Surgery
Keywords
PREUNI0710, cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
Ster ® (prednisolone 1% ophthalmic suspension - União Química)
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Pred Fort ® (prednisolone 1% ophthalmic suspension - Allergan)
Intervention Type
Drug
Intervention Name(s)
Ster
Intervention Description
prednisolone 1% ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
Pred Fort
Intervention Description
prednisolone 1% ophthalmic suspension
Primary Outcome Measure Information:
Title
Comparison of clinical efficacy between the test and comparator drugs by measuring periodic scores of efficacy in established clinical parameters.
Description
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.
Time Frame
28 days of treatment.
Secondary Outcome Measure Information:
Title
Comparison of safety data observed during the study period by assessing frequency and intensity of adverse reactions, compared statistically between groups.
Description
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.
Time Frame
28 days of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who agree with all study procedures and sign, by his own free will, IC;
Adult patients, regardless of gender, ethnicity or social status, with good mental health;
Patients who present at screening visit, a clinical diagnosis of cataract with an indication for corrective surgery with phacoemulsification technique.
Exclusion Criteria:
Patients with a history or clinical diagnosis of other eye diseases such as glaucoma, corneal ulcers, scarring, and uveitis;
Patients with known hypersensitivity to any component of the drug under investigation;
Patients who have made use of systemic corticosteroids within 15 days before surgery;
Patients who have made use of topical corticosteroids in the 7 days before surgery;
Patients who have made use of systemic antibiotics in the 15 days preceding surgery;
Patients who have made use of topical antibiotics in the 7 days before surgery;
Patients presenting abnormality, at the discretion of the principal investigator in the following ophthalmic examinations Preoperative slit-lamp examination, measurement of intraocular pressure (applanation tonometry) and examination of background, other than the underlying disease (cataract);
Pregnant or lactating women.
Facility Information:
Facility Name
LAL Clínica Pesquisa e Desenvolvimento Ltda
City
Valinhos
State/Province
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Clinical Efficacy of the Drug Ster® Compared With Predfort® in Control of Postoperative Inflammation in Cataract Surgery
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