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

Blepharitis Clinical Trial

— BRA-07-02  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732446
• Other study ID #: BRA-07-02
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2008
• Last updated: June 21, 2011
• Start date: August 2008
• Est. completion date: February 2009

Study information

• Verified date: August 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharitis
• Conjunctivitis
• Keratitis

Intervention

Drug:
• Moxifloxacin and Dexamethasone combined
moxifloxacin 0,5% qid and dexamethasone 0,1% qid combined
• Moxifloxacin
moxifloxacin 0,5% qid and
• Dexamethasone
dexamethasone 0,1% qid

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Alcon Research

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of ocular sign/symptoms (hyperemia on bulbar conjunctiva, palpebral conjunctiva, conjunctival exsudates, palpebral erythema at final visit (Day 8)		Day 8	Yes
Secondary	Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis		Day 8	Yes