Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis - Full Text View

Sponsor:	Federal University of São Paulo
Collaborator:	Alcon Research
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00732446

Purpose

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
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)

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Pinkeye

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Moxifloxacin Moxifloxacin hydrochloride Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8) [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]

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
2: Active Comparator antibiotic /steroid combination compared with individual administration of steroid and antibiotic	Drug: Moxifloxacin moxifloxacin 0,5% qid and Drug: Dexamethasone dexamethasone 0,1% qid
1: Experimental combination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication	Drug: Moxifloxacin and Dexamethasone combined moxifloxacin 0,5% qid and dexamethasone 0,1% qid combined

Detailed Description:

Antibiotic/steroid combination compared to individuals components 8 days of treatment.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732446

Contacts

Contact: Rubens Belfort, MD	5511-5572-6443	clinbelf@uol.com.br
Contact: Luci Silva, MBA	5511-5084-5878	luci@oftalmo.epm.br

Locations

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

Sponsors and Collaborators

Federal University of São Paulo

Alcon Research

Investigators

Principal Investigator:

Rubens Belfort, MD

Federal University of Sao Paulo

More Information

No publications provided

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

Keywords provided by Federal University of São Paulo:

moxifloxacin
dexamethasone
ocular inflammation
ocular infection

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 08, 2010