Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis
Information source: InSite Vision
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Blepharoconjunctivitis
Intervention: 1% Azithromycin and 0.1% Dexamethasone (Drug); 1% Azithromycin (Drug); 0.1% Dexamethasone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: InSite Vision Overall contact:
Aron Shapiro, Phone: 866-393-3767 or 978-685-8900, Ext: 243, Email: ashapiro@oraclinical.com
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: The resolution of the clinical signs and symptoms.
Secondary outcome: Bacterial eradication
Eligibility
Minimum age: 1 Year.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Aron Shapiro, Phone: 866-393-3767 or 978-685-8900, Ext: 243, Email: ashapiro@oraclinical.com
Ophthalmic Research Associates, Inc., North Andover, Massachusetts 01845, United States; Recruiting
Additional Information
Starting date: December 2007
Ending date: January 2009
Last updated: April 21, 2008
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