Trial | NCT00578955  Report issue

Title

Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis
A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical and Anti-Microbial Efficacy and Safety of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone in the Treatment of Subjects With Blepharoconjunctivitis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    urea azithromycin ...

  • Study Participants

    417
The purpose of this study is to determine if AzaSite Plus is effective and safe for the treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.
Study Started
Dec 31
2007
Primary Completion
Oct 31
2008
Study Completion
Oct 31
2008
Last Update
Nov 19
2021

Drug 1% Azithromycin and 0.1% Dexamethasone

Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

  • Other names: AzaSite Plus

Drug 1% Azithromycin

Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

  • Other names: AzaSite

Drug 0.1% Dexamethasone

Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.

  • Other names: Dexamethasone

1 Experimental

2 Active Comparator

3 Active Comparator

Criteria 

Inclusion Criteria:

Have a clinical diagnosis of blepharoconjunctivitis
Must be willing to discontinue contact lens wear for the duration of the study
Additional inclusion criteria also apply.

Exclusion Criteria:

Have known sensitivity or poor tolerance to any component of the study medications.
Have any clinically significant cardiovascular disorders
Have any history of liver or kidney disease resulting in persisting dysfunction
Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device.
Additional exclusion criteria also apply.
No Results Posted