Status:
UNKNOWN
Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis
Lead Sponsor:
Azidus Brasil
Conditions:
Acute Bacterial Conjunctivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 TOB...
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 quanti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01227915
Start Date
February 1 2011
Last Update
October 25 2010
Active Locations (1)
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1
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil