Clinical Efficacy of the Drug Ster® Compared With Predfort® in Control of Postoperative Inflammation in Cataract Surgery

Phase 3

Completed

• Conditions: Inflammation; Cataract Surgery
• Interventions: Drug: Ster; Drug: Pred Fort

• Registration Number: NCT01227876
• Lead Sponsor: Azidus Brasil

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.

Study Timeline

• Study First Submitted: 2010-10-15
• Study First Submitted QC: 2010-10-22
• Study First Posted: 2010-10-25
• Study Start: 2011-01
• Primary Completion: 2011-02
• Study Completion: 2011-08
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Ster	Ster ® (prednisolone 1% ophthalmic suspension - União Química)
Comparator	Pred Fort	Pred Fort ® (prednisolone 1% ophthalmic suspension - Allergan)

Primary Outcome Measures

Name	Time	Method
Comparison of clinical efficacy between the test and comparator drugs by measuring periodic scores of efficacy in established clinical parameters.	28 days of treatment.	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

Name	Time	Method
Comparison of safety data observed during the study period by assessing frequency and intensity of adverse reactions, compared statistically between groups.	28 days of treatment.	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.

Trial Locations

Locations (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda; 🇧🇷 Valinhos, São Paulo, Brazil