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

Inflammation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227876
• Other study ID #: PREUNI0710
• Secondary ID: Version 01
• Status: Completed
• Phase: Phase 3
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: October 2022
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery
• Inflammation

Intervention

Drug:
• Ster
prednisolone 1% ophthalmic suspension
• Pred Fort
prednisolone 1% ophthalmic suspension

Locations

Country	Name	City	State
Brazil	LAL Clínica Pesquisa e Desenvolvimento Ltda	Valinhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Azidus Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of safety data observed during the study period by assessing frequency and intensity of adverse reactions, compared statistically between groups.	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.