Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InSite Vision; Sun Pharma Global FZE
• Treatments: Azithromycin; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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