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Antibiotic Steroid Combination Compared With Individual Administration in the in the Treatment of Ocular Inflammation and Infection

NCT01721694 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-12-11

No results posted yet for this study

Summary

To evaluate the efficacy and safety of fixed combination of azithromycin 1.5% + 0.5% Loteprednol eye drops for the treatment of ocular inflammation and infection associated bacterial blepharitis and / or keratitis and / or conjunctivitis compared with the individual administration of azithromycin 1.5% and 0.5% Loteprednol (separately).

Conditions

  • Ocular Inflammation
  • Infection Associated Blepharitis
  • Keratitis
  • Conjunctivitis, Bacterial

Interventions

DRUG

azithromycin 1.5%/Loteprednol 0,5% + placebo

1 drop, AO, QID

DRUG

azithromycin 1.5% + Loteprednol 0,5% (separately)

1 drop, QID, AO

Sponsors & Collaborators

  • Adapt Produtos Oftalmológicos Ltda.

    lead INDUSTRY

Principal Investigators

  • Rubens Belfort Jr., MD · Federal University of São Paulo / Hospital São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-03-31
Completion
2013-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01721694 on ClinicalTrials.gov