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

Azidus

Status and phase

Completed

Phase 3

Conditions

Inflammation

Cataract Surgery

Treatments

Drug: Pred Fort

Drug: Ster

Study type

Interventional

Funder types

Industry

Identifiers

NCT01227876

Version 01

PREUNI0710

Details and patient eligibility

About

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).

Full 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.

Enrollment

106 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.