Clinical trial NCT01227915: Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis
Official title: RANDOMIZED CLINICAL EVALUATION OF EFFECTIVENESS COMPARISON BETWEEN DRUGS OPHTHALMOLOGICAL TOBRACORT® (TOBRAMYCIN + DEXAMETHASONE - LAB. UNIÃO QUÍMICA)AND TOBRADEX® (TOBRAMYCIN + DEXAMETHASONE - LAB. ALCON) IN REDUCING THE SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Bacterial Conjunctivitis
Keywords: SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2010-10-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment.
timeFrame: 7 days of treatment
Secondary outcomes:
measure: Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter established.
timeFrame: 7 days of treatment.
measure: Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
timeFrame: 7 days of treatment.
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clínica Pesquisa e Desenvolvimento Ltda
state: São Paulo
Study officials:
References: