Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate, through clinical parameters, the comparative efficacy between topical Tobracort ® (tobramycin 0.3% dexamethasone + 1% - Chemistry Lab Union) and TOBRADEX ® (tobramycin 0.3% dexamethasone + 1 % - Alcon Lab), using the percentage of improvement (sustained response rate) at the end of treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azidus Brasil
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Tobramycin; Tobramycin, Dexamethasone Drug Combination

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 picture of acute bacterial conjunctivitis diagnosed clinically.

Exclusion Criteria:

• Patients with clinical diagnosis of conjunctivitis due to any process other than bacterial infection, such as infections by fungi, protozoa, viruses, or allergic conjunctivitis;

• Patients with a history or clinical diagnosis of other lesions that may affect the outcome, such as glaucoma, corneal ulcer or scars;

• Patients with known hypersensitivity to any component of the study drug;

• Concomitant use of ocular medication other than the study;

• Patients who have made use of systemic anti-inflammatory hormone in the 30 days preceding inclusion;

• Patients who have made use of systemic antibiotics in the 15 days preceding inclusion;

• Pregnant or lactating women;

• Being or having been treated for any type of conjunctivitis is less than 15 days, or have finished treatment at least 7 days