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

Azidus

Status and phase

Unknown

Phase 3

Conditions

Acute Bacterial Conjunctivitis

Treatments

Drug: Tobracort

Drug: Tobradex

Study type

Interventional

Funder types

Industry

Identifiers

NCT01227915

Version 01

TODUNI0610

Details and patient eligibility

About

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.

Full description

Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter;
Observation and statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.

Enrollment

70 estimated 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 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