Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Eye Infections; Bacterial Infections

Treatments: Drug: Moxifloxacin; Drug: Azithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00564447

P08654

041-102

Details and patient eligibility

About

The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have best corrected visual acuity of 0.60 logMAR or better in each eye as measured using Early Treatment of Diabetic Retinopathy Study chart

Exclusion criteria

• Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the trial
• Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)
• Have a known bleeding disorder or history of bleeding complications after surgical or dental procedures
• Take aspirin, or take any other blood thinners or anti-coagulants (e.g. warfarin) including prescription, over the counter, or homeopathic therapies
• Have undergone any ocular surgical intervention within 3 months prior to Visit 1 or anticipate having ocular surgery during the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 8 patient groups

Azithromycin-30 minutes Post dose

Experimental group

Treatment:

Drug: Azithromycin

Azithromycin-2 hours post dose

Experimental group

Treatment:

Drug: Azithromycin

Azithromycin-12 hours post dose

Experimental group

Treatment:

Drug: Azithromycin

Azithromycin-24 hours post dose

Experimental group

Treatment:

Drug: Azithromycin

Moxifloxacin-30 minutes post dose

Experimental group

Treatment:

Drug: Moxifloxacin

Moxifloxacin-2 hours post dose

Experimental group

Treatment:

Drug: Moxifloxacin

Moxifloxacin-12 hours post dose

Experimental group

Treatment:

Drug: Moxifloxacin

Moxafloxacin-24 hours post dose

Experimental group

Treatment:

Drug: Moxifloxacin