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
  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:


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
Antibiotics, Antitubercular
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on April 16, 2014