Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis
Phase 3
Completed
- Conditions
- Blepharoconjunctivitis
- Interventions
- Registration Number
- NCT00578955
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 417
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 0.1% Dexamethasone - 1 1% Azithromycin and 0.1% Dexamethasone - 2 1% Azithromycin -
- Primary Outcome Measures
Name Time Method The resolution of the clinical signs and symptoms. 2 weeks
- Secondary Outcome Measures
Name Time Method Bacterial eradication 2 weeks