Efficacy Maxinom® And Maxitrol® in Reducing The Signs And Symptoms Of Acute Bacterial Conjunctivitis
Information source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Conjunctivitis; Acute
Intervention: MAXINOM® (Drug); Maxitrol® (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Summary
The primary objective of this study is to evaluate, through clinical parameters, the
effectiveness of your medicine topic Maxinom ® (dexamethasone, neomycin and polymyxin B -
Union Chemicals), comparing it to the topical medication Maxitrol ® (dexamethasone, neomycin
and polymyxin B - Alcon ) by the percentage of improvement (sustained response rate) at the
end of treatment, among the products studied.
Clinical Details
Official title: Randomized Clinical Trial Of Drug Topics Efficacy Maxinom® (Dexamethasone + Neomycin Sulfate + Polymyxin B Sulfate - Lab. Union Chemical) And Maxitrol® (Dexamethasone + Neomycin Sulfate + Polymyxin B Sulfate - Lab. Alcon) In Reducing The Signs And Symptoms Of Acute Bacterial Conjunctivitis
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Compared effectiveness between drugs using percentage of improvement (sustained response rate) at the end of treatment.
Secondary outcome: Evaluation of signs and symptoms during treatment with a record of individual scores for each parameter established.Statical comparison of drug safety by recording qualitative and quantitative parameter related to adverse effects occurring during treatment.
Detailed description:
1. Evaluation of isolated signs and symptoms during treatment, with a record of individual
scores for each parameter and observation
2. Statistical comparison of drug safety, by recording qualitative and quantitative
parameters related to adverse effects occurring during treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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, picture of acute bacterial
conjunctivitis diagnosed clinically.
Exclusion Criteria:
- Patients with clinical diagnosis or suspicion of conjunctivitis due to any process
that is not due to bacterial infection, such as infections by fungi, protozoa,
viruses and allergic conjunctivitis;
- Patients with known hypersensitivity to any component of the formulas of the
study drugs;
- Patients with a history or clinical diagnosis of other lesions that may affect
the outcome, such as glaucoma, corneal ulcer or scars;
- Concomitant use of ocular medication other than the study;
- Pregnant or lactating women;
- Being or having been treated for any type of conjunctivitis within 15 days and
have finished treatment or less than 07 days
Locations and Contacts
LAL Clinica Pesquisa e Desenvolvimento Ltda, Valinhos, São Paulo, Brazil; Not yet recruiting Alexandre Frederico, doctor, Phone: 55 19 3871-6399, Email: alexandre@lalclinica.com.br Jose Roberto de Camargo, doctor, Principal Investigator
Additional Information
Starting date: February 2011
Last updated: October 22, 2010
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