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

Phase 3

Completed

• Conditions: Blepharitis; Conjunctivitis; Keratitis
• Interventions: Drug: Moxifloxacin and Dexamethasone combined; Drug: Moxifloxacin; Drug: Dexamethasone

• Registration Number: NCT00732446
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Status Verified: 2008-08
• Study Start: 2008-08
• Study First Submitted: 2008-08-11
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-12
• Primary Completion: 2008-12
• Study Completion: 2009-02
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Moxifloxacin and Dexamethasone combined	combination antibiotic steroid compared with individual administration of steroid and antibiotic - new therapeutic indication
2	Moxifloxacin	antibiotic /steroid combination compared with individual administration of steroid and antibiotic
2	Dexamethasone	antibiotic /steroid combination compared with individual administration of steroid and antibiotic

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis	Day 8

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 sao Paulo, SP, Brazil