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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00732446

Acronym

BRA-07-02

Enrollment

100

Registered

2008-08-12

Start date

2008-08-31

Completion date

2009-02-28

Last updated

2011-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blepharitis, Conjunctivitis, Keratitis

Keywords

moxifloxacin, dexamethasone, ocular inflammation, ocular infection

Brief summary

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).

Detailed description

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

Interventions

DRUGMoxifloxacin and Dexamethasone combined

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

DRUGMoxifloxacin

moxifloxacin 0,5% qid and

DRUGDexamethasone

dexamethasone 0,1% qid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis	Day 8

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026