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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Study Primary Completion Date: January 2009

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

Primary Measures

• The resolution of the clinical signs and symptoms.
  • Time Frame: 2 weeks
    Safety Issue?: No

Secondary Measures

• Bacterial eradication
  • Time Frame: 2 weeks
    Safety Issue?: No

Inclusion Criteria:

• Have a clinical diagnosis of blepharoconjunctivitis
• Must be willing to discontinue contact lens wear for the duration of the study
• Have best corrected visual acuity of 20/100 in both eyes.
• Have IOP less than or equal to 25 mmHg in either eye

Exclusion Criteria:

• Have known sensitivity or poor tolerance to any component of the study medications.
• Have a history of eyelid and/or ocular surgery and/or have had ocular surgical intervention within 6 months prior to visit 1 or during the study and/or a history of refractive surgery within 6 months.
• Have worn contact lenses 72 hours prior to visit 1 and/or need to wear contact lenses for the duration of the study.
• Have used any topical ophthalmic solutions including tear substitutes within 2 hours of enrollment.
• Use of any eye make-up during the study.
• Have any uncontrolled systemic disease or debilitating disease
• Have been diagnosed with glaucoma
• 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.

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

Lead Sponsor: InSite Vision

Overall Clinical Trial Officials and Contacts

Overall Contact: Aron Shapiro 866-393-3767 or 978-685-8900 ashapiro@oraclinical.com

Information obtained from ClinicalTrials.gov on September 05, 2008

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