NCT01721694

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

Association of Azithromycin 1,5%/Loteprednol 0,5% Eye Drops Versus Individual Administration of Azithromycin 1,5% and Loteprednol 0,5% in the Treatment of Ocular Inflammation and Infection

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Adapt Produtos Oftalmológicos Ltda. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Estimated to be admitted a total of approximately 60 patients showing blepharitis and / or keratitis and / or conjunctivitis: 30 patients will be assigned to the group of Azithromycin 1.5%/Loteprednol 0.5% Eye Drops (fixed combination) + placebo and 30 patients will be assigned to the group of Azithromycin 1.5% + 0.5% Loteprednol (separately)

Conditions

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

Interventions

Type	Name	Description
DRUG	azithromycin 1.5%/Loteprednol 0,5% + placebo	1 drop, AO, QID
DRUG	azithromycin 1.5% + Loteprednol 0,5% (separately)	1 drop, QID, AO

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-03-01
• Completion: 2013-05-01
• First posted: 2012-11-06
• Last updated: 2014-12-11

Locations

1 site across 1 country: Brazil