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Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis (BRA-07-02)

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00732446
First received: August 11, 2008
Last updated: June 21, 2011
Last verified: August 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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
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
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
antibiotic /steroid combination compared with individual administration of steroid and antibiotic
 Drug: Moxifloxacin
moxifloxacin 0,5% qid and
Other Name: maxidex and vigamox
Drug: Dexamethasone
dexamethasone 0,1% qid
Experimental: 1
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
Other Name: vigadexa

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

Locations
Brazil
Federal University of Sao Paulo
sao Paulo, SP, Brazil, 04040002
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: Rubens Belfort Jr. - Full Professor of Ophthalmology, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00732446     History of Changes
Other Study ID Numbers: BRA-07-02
Study First Received: August 11, 2008
Last Updated: June 21, 2011
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:
Blepharitis
Conjunctivitis
Inflammation
Keratitis
Eyelid Diseases
Eye Diseases
Conjunctival Diseases
Pathologic Processes
Corneal Diseases
Anti-Bacterial Agents
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Moxifloxacin
 Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 16, 2013