Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis
Information source: Federal University of São Paulo
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Blepharitis; Conjunctivitis; Keratitis
Intervention: Moxifloxacin and Dexamethasone combined (Drug); Moxifloxacin (Drug); Dexamethasone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Federal University of São Paulo Official(s) and/or principal investigator(s):
Rubens Belfort, MD, Principal Investigator, Affiliation: Federal University of Sao Paulo
Overall contact:
Rubens Belfort, MD, Phone: 5511-5572-6443, Email: clinbelf@uol.com.br
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).
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8)
Secondary outcome: Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis
Detailed description:
Antibiotic/steroid combination compared to individuals components 8 days of treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Rubens Belfort, MD, Phone: 5511-5572-6443, Email: clinbelf@uol.com.br
Federal University of Sao Paulo, sao Paulo, SP 04040002, Brazil; Recruiting
Rubens Belfort, MD, Phone: 5511-5572-6443, Email: clinbelf@uol.com.br
Luci Silva, MBA, Phone: 5511-5084-5878, Email: luci@oftalmo.epm.br
Rubens Belfort Jr, MD, Principal Investigator
Cristina Muccioli, MD, Sub-Investigator
Luis AR Gabriel, MD, Sub-Investigator
Additional Information
Starting date: August 2008
Ending date: February 2009
Last updated: September 22, 2008
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