Phase 4
Completed N=48
Study of AzaSite (Azithromycin) Versus Vigamox in the Conjunctiva of Healthy Volunteers
Bacterial Infections · Eye Infections
Source: ClinicalTrials.gov NCT00564447 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcomePrimary: Assessment of Pharmacokinetic Parameters
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Pharmacokinetic Parameters |
130.8; 51.6; 67.1; 31.9; 1.9; 3.8 | — |
| PRIMARY Assessment of Pharmacokinetic Parameters |
130.8; 51.6; 67.1; 31.9; 1.9; 3.8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00564447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.