Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis
BRA-07-02
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)
1 other identifier
interventional
100
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 11, 2008
CompletedFirst Posted
Study publicly available on registry
August 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedJune 22, 2011
August 1, 2008
4 months
August 11, 2008
June 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8)
Day 8
Secondary Outcomes (1)
Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis
Day 8
Study Arms (2)
2
ACTIVE COMPARATORantibiotic /steroid combination compared with individual administration of steroid and antibiotic
1
EXPERIMENTALcombination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication
Interventions
moxifloxacin 0,5% qid and dexamethasone 0,1% qid combined
Eligibility Criteria
You may qualify if:
- Patients with diagnosis of blepharitis and/or keratitis and/or bacterial conjunctivitis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Federal University of São Paulolead
- Alcon Researchcollaborator
Study Sites (1)
Federal University of Sao Paulo
São Paulo, São Paulo, 04040002, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rubens Belfort, MD
Federal University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 11, 2008
First Posted
August 12, 2008
Study Start
August 1, 2008
Primary Completion
December 1, 2008
Study Completion
February 1, 2009
Last Updated
June 22, 2011
Record last verified: 2008-08