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 October 04, 2010
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: Not yet recruiting
Sponsored by: InSite Vision Overall contact:
Aron Shapiro, Phone: 866-393-3767, 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: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Resolution of the clinical signs and symptoms.
Secondary outcome: Bacterial eradication
Eligibility
Minimum age: 12 Years.
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 6/24 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, Ext: 243, Email: ashapiro@oraclinical.com Additional Information
Starting date: November 2008
Last updated: October 29, 2008
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