Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis
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...
Brief Summary
Official Title: “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”
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 Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: October 2008
Intervention(s) in this Clinical Trial
- 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.
- Drug: 1% Azithromycin
- Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.
- 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.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Active Comparator: 2
- Active Comparator: 3
Outcome Measures for this Clinical Trial
Primary Measures
- The resolution of the clinical signs and symptoms.
- Time Frame: 2 weeks
Safety Issue?: No
- Time Frame: 2 weeks
Secondary Measures
- Bacterial eradication
- Time Frame: 2 weeks
Safety Issue?: No
- Time Frame: 2 weeks
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Year
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: InSite Vision Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00578955
Study ID Number: C-07-502-002
ClinicalTrials.gov Identifier: NCT00578955
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00578955
