Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis
Phase 3
Completed
- Conditions
- BlepharitisConjunctivitisKeratitis
- Interventions
- Registration Number
- NCT00732446
- Lead Sponsor
- Federal University of São Paulo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Moxifloxacin and Dexamethasone combined combination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication 2 Moxifloxacin antibiotic /steroid combination compared with individual administration of steroid and antibiotic 2 Dexamethasone antibiotic /steroid combination compared with individual administration of steroid and antibiotic
- Primary Outcome Measures
Name Time Method 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
Name Time Method Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis Day 8
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which moxifloxacin and dexamethasone synergistically treat bacterial ocular inflammation and infection?
How does the fixed combination of moxifloxacin 0.5% and dexamethasone 0.1% compare to standard-of-care antibiotic-steroid regimens in treating blepharitis, conjunctivitis, and keratitis?
Which biomarkers are associated with improved clinical outcomes in patients treated with moxifloxacin-dexamethasone combinations for bacterial keratitis or conjunctivitis?
What are the potential adverse events and management strategies for using moxifloxacin and dexamethasone combination therapy in ocular infections?
How do moxifloxacin-dexamethasone combinations compare to other antibiotic-steroid combinations like tobramycin-dexamethasone in treating anterior uveitis or infectious keratitis?
Trial Locations
- Locations (1)
Federal University of Sao Paulo
🇧🇷sao Paulo, SP, Brazil
Federal University of Sao Paulo🇧🇷sao Paulo, SP, Brazil