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

Sun Pharma

Status and phase

Withdrawn

Phase 3

Conditions

Blepharoconjunctivitis

Treatments

Drug: 1% Azithromycin and 0.1% Dexamethasone

Drug: 0.1% Dexamethasone

Drug: 1% Azithromycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00754949

C-07-502-003

Details and patient eligibility

About

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.

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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