Clinical trial NCT01227876: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation
Cataract Surgery
Keywords: PREUNI0710
cataract
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2010-10-25
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Comparison of clinical efficacy between the test and comparator drugs by measuring periodic scores of efficacy in established clinical parameters.
timeFrame: 28 days of treatment.
Secondary outcomes:
measure: Comparison of safety data observed during the study period by assessing frequency and intensity of adverse reactions, compared statistically between groups.
timeFrame: 28 days of treatment.
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clínica Pesquisa e Desenvolvimento Ltda
state: São Paulo
Study officials:
References: