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

Acute Bacterial Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01227915
• Other study ID #: TODUNI0610
• Secondary ID: Version 01
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 15, 2010
• Last updated: October 22, 2010
• Start date: February 2011

Study information

• Verified date: October 2010
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial
• Signs and Symptoms

Intervention

Drug:
• Tobracort
tobramycin 0.3% + dexamethasone 1%
• Tobradex
tobramycin 0.3% + dexamethasone 1%

Locations

Country	Name	City	State
Brazil	LAL Clínica Pesquisa e Desenvolvimento Ltda	Valinhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No
Secondary	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.	No