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

Federal University of São Paulo

Status and phase: Completed; Phase 3

Conditions: Blepharitis; Conjunctivitis; Keratitis

Treatments: Drug: Moxifloxacin; Drug: Moxifloxacin and Dexamethasone combined; Drug: Dexamethasone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00732446

BRA-07-02

Details and patient eligibility

About

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).

Full description

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

2

Active Comparator group

Description:

antibiotic /steroid combination compared with individual administration of steroid and antibiotic

Treatment:

Drug: Dexamethasone

Drug: Moxifloxacin

1

Experimental group

Description:

combination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication

Treatment:

Drug: Moxifloxacin and Dexamethasone combined