Status:
COMPLETED
Clinical Efficacy of the Drug Ster® Compared With Predfort® in Control of Postoperative Inflammation in Cataract Surgery
Lead Sponsor:
Azidus Brasil
Conditions:
Inflammation
Cataract Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 (pre...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01227876
Start Date
January 1 2011
End Date
August 1 2011
Last Update
November 2 2022
Active Locations (1)
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1
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil