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OpenTrials
Completed

NCT Number: NCT00732446

Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis

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).

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Key information

Conditions

Blepharitis Conjunctival Diseases Conjunctivitis Corneal Diseases Eye Diseases Eye Infections Eyelid Diseases Infections Keratitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Federal University of Sao Paulo

São Paulo, 04040002, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moxifloxacin and Dexamethasone combined

Drug

moxifloxacin 0,5% qid and dexamethasone 0,1% qid combined

Other names: vigadexa

moxifloxacin

Drug

moxifloxacin 0,5% qid and

Other names: maxidex and vigamox

Dexamethasone

Drug

dexamethasone 0,1% qid

Primary outcomes

  1. Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8)

    Time frame: Day 8

Secondary outcomes

  1. Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis

    Time frame: Day 8

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Alcon Research

Registry information

Official study 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)

Acronym: BRA-07-02

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Aug 12, 2008
Registry last updated
Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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