Back to resultsSafety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis (BRA-07-02)
Primary Purpose
Blepharitis, Conjunctivitis, Keratitis
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Moxifloxacin and Dexamethasone combined
Moxifloxacin
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Blepharitis focused on measuring moxifloxacin, dexamethasone, ocular inflammation, ocular infection
Eligibility Criteria
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
Sites / Locations
- Federal University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
2
1
Arm Description
antibiotic /steroid combination compared with individual administration of steroid and antibiotic
combination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication
Outcomes
Primary Outcome Measures
Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8)
Secondary Outcome Measures
Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis
Full Information
NCT ID
NCT00732446
First Posted
August 11, 2008
Last Updated
June 21, 2011
Sponsor
Federal University of São Paulo
Collaborators
Alcon Research
1. Study Identification
Unique Protocol Identification Number
NCT00732446
Brief Title
Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis
Acronym
BRA-07-02
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 Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
Collaborators
Alcon Research
4. Oversight
Data Monitoring Committee
Yes
5. 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).
Detailed Description
Antibiotic/steroid combination compared to individuals components 8 days of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis, Conjunctivitis, Keratitis
Keywords
moxifloxacin, dexamethasone, ocular inflammation, ocular infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
antibiotic /steroid combination compared with individual administration of steroid and antibiotic
Arm Title
1
Arm Type
Experimental
Arm Description
combination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin and Dexamethasone combined
Other Intervention Name(s)
vigadexa
Intervention Description
moxifloxacin 0,5% qid and dexamethasone 0,1% qid combined
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
maxidex and vigamox
Intervention Description
moxifloxacin 0,5% qid and
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
dexamethasone 0,1% qid
Primary Outcome Measure Information:
Title
Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8)
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis
Time Frame
Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens Belfort, MD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
sao Paulo
State/Province
SP
ZIP/Postal Code
04040002
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis
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