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Sponsors and Collaborators: |
Federal University of São Paulo Alcon Research |
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Information provided by: | Federal University of São Paulo |
ClinicalTrials.gov Identifier: | NCT00732446 |
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 | Intervention | Phase |
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Blepharitis Conjunctivitis Keratitis |
Drug: Moxifloxacin and Dexamethasone combined Drug: Moxifloxacin Drug: Dexamethasone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 100 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator
antibiotic /steroid combination compared with individual administration of steroid and antibiotic
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Drug: Moxifloxacin
moxifloxacin 0,5% qid and
Drug: Dexamethasone
dexamethasone 0,1% qid
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1: Experimental
combination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication
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Drug: Moxifloxacin and Dexamethasone combined
moxifloxacin 0,5% qid and dexamethasone 0,1% qid combined
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Antibiotic/steroid combination compared to individuals components 8 days of treatment.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rubens Belfort, MD | 5511-5572-6443 | clinbelf@uol.com.br |
Contact: Luci Silva, MBA | 5511-5084-5878 | luci@oftalmo.epm.br |
Brazil, SP | |
Federal University of Sao Paulo | Recruiting |
sao Paulo, SP, Brazil, 04040002 | |
Contact: Rubens Belfort, MD 5511-5572-6443 clinbelf@uol.com.br | |
Contact: Luci Silva, MBA 5511-5084-5878 luci@oftalmo.epm.br | |
Principal Investigator: Rubens Belfort Jr, MD | |
Sub-Investigator: Cristina Muccioli, MD | |
Sub-Investigator: Luis AR Gabriel, MD |
Principal Investigator: | Rubens Belfort, MD | Federal University of Sao Paulo |
Responsible Party: | Federal University of Sao Paulo ( Rubens Belfort Jr. - Full Professor of Ophthalmology ) |
Study ID Numbers: | BRA-07-02 |
Study First Received: | August 11, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00732446 History of Changes |
Health Authority: | Brazil: National Health Surveillance Agency |
moxifloxacin dexamethasone ocular inflammation ocular infection |
Anti-Inflammatory Agents Dexamethasone Corneal Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Eye Diseases Eye Infections Blepharitis Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Conjunctivitis |
Tetrahydrozoline Hormones Glucocorticoids Conjunctival Diseases Inflammation Anti-Bacterial Agents Moxifloxacin Keratitis Peripheral Nervous System Agents Dexamethasone acetate |
Dexamethasone Anti-Inflammatory Agents Anti-Infective Agents Antineoplastic Agents Blepharitis Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Moxifloxacin Therapeutic Uses Eyelid Diseases Dexamethasone acetate |
Corneal Diseases Antineoplastic Agents, Hormonal Eye Diseases Gastrointestinal Agents Conjunctivitis Glucocorticoids Conjunctival Diseases Pharmacologic Actions Autonomic Agents Keratitis Peripheral Nervous System Agents Central Nervous System Agents |