Phase 4
Completed N=37
Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
Bacterial Infections · Eye Infections
Source: ClinicalTrials.gov NCT00575367 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Sep 2009
Primary outcomePrimary: Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. — 16.485; 8.199; 4.007; 2.221 µg/mL
Summary
The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. |
16.485; 8.199; 4.007; 2.221; 1.966; 2.985 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00575367). 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.