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

NCT ID: NCT01227876

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-08-31

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.

Conditions

Inflammation; Cataract Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test

Ster ® (prednisolone 1% ophthalmic suspension - União Química)

Group Type: EXPERIMENTAL

Ster

Intervention Type: DRUG

prednisolone 1% ophthalmic suspension

Comparator

Pred Fort ® (prednisolone 1% ophthalmic suspension - Allergan)

Group Type: ACTIVE_COMPARATOR

Pred Fort

Intervention Type: DRUG

prednisolone 1% ophthalmic suspension

Interventions

Ster

prednisolone 1% ophthalmic suspension

Intervention Type: DRUG

Pred Fort

prednisolone 1% ophthalmic suspension

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Version 01

Identifier Type: -

Identifier Source: secondary_id

PREUNI0710

Identifier Type: -

Identifier Source: org_study_id