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

NCT01227915 | Unknown Phase 3

• 2 other identifiers: TODUNI0610Version 01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Bacterial Conjunctivitis

Keywords

SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter established.

  7 days of treatment.

• Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.

  7 days of treatment.

Study Arms (2)

Test

EXPERIMENTAL

tobramycin 0.3% + dexamethasone 1% - União Química Lab

Drug: Tobracort

Comparator

ACTIVE COMPARATOR

tobramycin 0.3% + dexamethasone 1% - Alcon Lab

Drug: Tobradex

Interventions

Tobracort DRUG

tobramycin 0.3% + dexamethasone 1%

Test

Tobradex DRUG

tobramycin 0.3% + dexamethasone 1%

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Location

MeSH Terms

Interventions

Tobramycin, Dexamethasone Drug Combination

Intervention Hierarchy (Ancestors)

Dexamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Tobramycin; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 25, 2010
• Study Start: February 1, 2011
• Primary Completion: February 1, 2011
• Last Updated: October 25, 2010

Record last verified: 2010-10

Locations

BR (1)