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

Sponsor

Azidus Brasil (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01227876

Collaborator

(none)

106

Enrollment

Location

Arms

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Inflammation Cataract Surgery	Drug: Ster Drug: Pred Fort	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Ster ® (prednisolone 1% ophthalmic suspension - União Química)	Drug: Ster prednisolone 1% ophthalmic suspension
Active Comparator: Comparator Pred Fort ® (prednisolone 1% ophthalmic suspension - Allergan)	Drug: Pred Fort prednisolone 1% ophthalmic suspension

Arm

Intervention/Treatment

Experimental: Test

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

Drug: Ster

prednisolone 1% ophthalmic suspension

Active Comparator: Comparator

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

Drug: Pred Fort

prednisolone 1% ophthalmic suspension

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.