Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis
Information source: InSite Vision
ClinicalTrials.gov processed this data on August 23, 2015
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
Sponsored by: InSite Vision
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
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