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

NCT01227876 | Completed Phase 3

• 2 other identifiers: PREUNI0710Version 01
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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).

Conditions

Inflammation; Cataract Surgery

Keywords

PREUNI0710; cataract

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days of treatment.

Secondary Outcomes (1)

• 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.

Study Arms (2)

Test

EXPERIMENTAL

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

Drug: Ster

Comparator

ACTIVE COMPARATOR

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

Drug: Pred Fort

Interventions

Ster DRUG

prednisolone 1% ophthalmic suspension

Test

Pred Fort DRUG

prednisolone 1% ophthalmic suspension

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Location

MeSH Terms

Conditions

Inflammation; Cataract

Interventions

Triclosan; Methylprednisolone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 25, 2010
• Study Start: January 1, 2011
• Primary Completion: February 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

BR (1)