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

Sponsor
Federal University of São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT00732446
Collaborator
Alcon Research (Industry)
100
Enrollment
1
Location
2
Arms
6
Duration (Months)
16.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Detailed Description

Antibiotic/steroid combination compared to individuals components 8 days of treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: 2

antibiotic /steroid combination compared with individual administration of steroid and antibiotic

Drug: Moxifloxacin
moxifloxacin 0,5% qid and
Other Names:
  • maxidex and vigamox
  • Drug: Dexamethasone
    dexamethasone 0,1% qid

    Experimental: 1

    combination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication

    Drug: Moxifloxacin and Dexamethasone combined
    moxifloxacin 0,5% qid and dexamethasone 0,1% qid combined
    Other Names:
  • vigadexa
  • Outcome Measures

    Primary Outcome Measures

    1. Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8) [Day 8]

    Secondary Outcome Measures

    1. Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis [Day 8]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Federal University of Sao Paulosao PauloSPBrazil04040002

    Sponsors and Collaborators

    • Federal University of São Paulo
    • Alcon Research

    Investigators

    • Principal Investigator: Rubens Belfort, MD, Federal University of Sao Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00732446
    Other Study ID Numbers:
    • BRA-07-02
    First Posted:
    Aug 12, 2008
    Last Update Posted:
    Jun 22, 2011
    Last Verified:
    Aug 1, 2008

    Study Results

    No Results Posted as of Jun 22, 2011