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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Bacterial Conjunctivitis
• Intervention / Treatment: Drug: Tobracort; Drug: Tobradex

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Valinhos, São Paulo, Brazil
      • LAL Clínica Pesquisa e Desenvolvimento Ltda
      • Contact: Alexandre Frederico, doctor; Phone Number: 55 19 3871-6399; Email: alexandre@lalclinica.com.br
      • Principal Investigator: Jose Roberto de Camargo, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; tobramycin 0.3% + dexamethasone 1% - União Química Lab	Drug: Tobracort; tobramycin 0.3% + dexamethasone 1%
Active Comparator: Comparator; tobramycin 0.3% + dexamethasone 1% - Alcon Lab	Drug: Tobradex; tobramycin 0.3% + dexamethasone 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment.	There will be a total of three returns after inclusion (0 day), and they are 1, 3 and 7 days after initiation of treatment.At the returns of 1 and 3 days, there will be a tolerance of +1 day, and the return of seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.	7 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter established.	There will be a total of three returns after inclusion (0 day), and they are 1, 3 and 7 days after initiation of treatment.At the returns of 1 and 3 days, there will be a tolerance of +1 day, and the return of seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.	7 days of treatment.
Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.	There will be a total of three returns after inclusion (0 day), and they are 1, 3 and 7 days after initiation of treatment.At the returns of 1 and 3 days, there will be a tolerance of +1 day, and the return of seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.	7 days of treatment.

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): February 1, 2011

Study Registration Dates

• First Submitted: October 15, 2010
• First Submitted That Met QC Criteria: October 22, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): October 25, 2010
• Last Update Submitted That Met QC Criteria: October 22, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Eye Infections, Bacterial; Eye Infections; Conjunctivitis; Conjunctivitis, Bacterial; Physiological Effects of Drugs; Anti-Infective Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Tobramycin, Dexamethasone Drug Combination
• Other Study ID Numbers: TODUNI0610; Version 01