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Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis (BRA-07-02)

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ClinicalTrials.gov Identifier: NCT00732446
Recruitment Status : Completed
First Posted : August 12, 2008
Last Update Posted : June 22, 2011
Sponsor:
Collaborator:
Alcon Research
Information provided by:
Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE August 11, 2008
First Posted Date  ICMJE August 12, 2008
Last Update Posted Date June 22, 2011
Study Start Date  ICMJE August 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2008)
Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8) [ Time Frame: Day 8 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2008)
evaluation of ocular sign/symptoms (hyperemy on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudatos, palpebral eritema at final visit (Day 8) [ Time Frame: Day 8 ]
Change History Complete list of historical versions of study NCT00732446 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2008)
Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis [ Time Frame: Day 8 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis
Official Title  ICMJE An Evaluation of the Safety and Efficacy of the Administration of a Fixed Combination of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops Compared With the Individual Administration of Moxifloxacin 0.5% and Dexamethasone 0.1% in the Treatment of Bacterial Ocular Inflammation and Infection (Blepharitis and/or Keratitis and/or Conjunctivitis)
Brief Summary Safety and efficacy of antibiotic steroid combination compared with individual administration in the treatment of bacterial ocular inflammation and infection (blepharitis and/or keratitis and/or conjunctivitis).
Detailed Description Antibiotic/steroid combination compared to individuals components 8 days of treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Blepharitis
  • Conjunctivitis
  • Keratitis
Intervention  ICMJE
  • Drug: Moxifloxacin and Dexamethasone combined
    moxifloxacin 0,5% qid and dexamethasone 0,1% qid combined
    Other Name: vigadexa
  • Drug: Moxifloxacin
    moxifloxacin 0,5% qid and
    Other Name: maxidex and vigamox
  • Drug: Dexamethasone
    dexamethasone 0,1% qid
Study Arms  ICMJE
  • Active Comparator: 2
    antibiotic /steroid combination compared with individual administration of steroid and antibiotic
    Interventions:
    • Drug: Moxifloxacin
    • Drug: Dexamethasone
  • Experimental: 1
    combination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication
    Intervention: Drug: Moxifloxacin and Dexamethasone combined
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 11, 2008)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with diagnosis of blepharitis and/or keratitis and/or bacterial conjunctivitis

Exclusion Criteria:

  • Uncontrolled glaucoma or intraocular hypertension
  • Wear contact lens during the study
  • Patients with sight in a single eye
  • Suspicious of viral, fungic infection
  • Use of any other ophthalmic drugs during the study
  • Use of immunosuppressant therapy
  • Known or suspected allergy or hypersensibility to any component of study medication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00732446
Other Study ID Numbers  ICMJE BRA-07-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rubens Belfort Jr. - Full Professor of Ophthalmology, Federal University of Sao Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Alcon Research
Investigators  ICMJE
Principal Investigator: Rubens Belfort, MD Federal University of Sao Paulo
PRS Account Federal University of São Paulo
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP