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

Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Blepharitis; Conjunctivitis; Keratitis

Intervention: Moxifloxacin and Dexamethasone combined (Drug); Moxifloxacin (Drug); Dexamethasone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Federal University of São Paulo

Official(s) and/or principal investigator(s):
Rubens Belfort, MD, Principal Investigator, Affiliation: Federal University of Sao Paulo


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).

Clinical Details

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

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

Secondary outcome: Evaluation of sign and symptoms of blepharitis and/or keratitis and/or bacterial conjunctivitis

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


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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

Locations and Contacts

Federal University of Sao Paulo, sao Paulo, SP 04040002, Brazil
Additional Information

Starting date: August 2008
Last updated: June 21, 2011

Page last updated: August 23, 2015

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