Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 4

Conditions

Eye Infections

Bacterial Infections

Treatments

Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution)

Drug: AzaSite (azithromycin ophthalmic solution)

Study type

Interventional

Funder types

Industry

Identifiers

041-101

P08653

Details and patient eligibility

About

The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Have visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study.
Have normal lid anatomy.

Exclusion criteria

Have an abnormal biomicroscopy or ophthalmoscopy exam.
Have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days.
Have used artificial tears in the past thirty days.
Have a diagnosis of on-going ocular infection or lid margin inflammation.
Have ever had penetrating ocular surface or intraocular surgery.
Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite.
Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox.
Have had corneal or lid abnormalities.
Have glaucoma, or Intra Ocular Pressure of 22 mm Hg or greater in one or both eyes.
Have any ocular pathology with the exception of cataracts.
Have a serious systemic disease or uncontrolled medical condition.
Have experienced symptoms of viral or allergic conjunctivitis in the past 30 days.
Have a history of liver or kidney disease resulting in persisting dysfunction.