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
Aron Shapiro, Phone: 866-393-3767, Ext: 243, Email: email@example.com
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.
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
Minimum age: 12 Years.
Maximum age: N/A.
- 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
- 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
- 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: firstname.lastname@example.orgAdditional Information
Starting date: November 2008
Last updated: October 29, 2008