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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-02-28

Brief Summary

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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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Detailed Description

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

Conditions

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Blepharitis Conjunctivitis Keratitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

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

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

moxifloxacin 0,5% qid and

Dexamethasone

Intervention Type DRUG

dexamethasone 0,1% qid

1

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

Group Type EXPERIMENTAL

Moxifloxacin and Dexamethasone combined

Intervention Type DRUG

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

Interventions

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Moxifloxacin and Dexamethasone combined

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

Intervention Type DRUG

Moxifloxacin

moxifloxacin 0,5% qid and

Intervention Type DRUG

Dexamethasone

dexamethasone 0,1% qid

Intervention Type DRUG

Other Intervention Names

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vigadexa maxidex and vigamox

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No