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

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT00732446

Collaborator

Alcon Research (Industry)

100

Enrollment

Location

Arms

Duration (Months)

16.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Blepharitis Conjunctivitis Keratitis	Drug: Moxifloxacin and Dexamethasone combined Drug: Moxifloxacin Drug: Dexamethasone	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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)

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 antibiotic /steroid combination compared with individual administration of steroid and antibiotic	Drug: Moxifloxacin moxifloxacin 0,5% qid and Other Names: 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 Names: vigadexa

Arm

Intervention/Treatment

Active Comparator: 2

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

Drug: Moxifloxacin

moxifloxacin 0,5% qid and

Other Names:

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 Names:

vigadexa

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis [Day 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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