Phase 3
Completed N=743
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
Bacterial Conjunctivitis
Source: ClinicalTrials.gov NCT00105469 ↗
Enrolled (actual)
743
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Number of Participants Who Achieved Clinical Resolution at Visit 3 — 127; 123 Participants
Summary
The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved Clinical Resolution at Visit 3 |
127; 123 | — |
| SECONDARY Number of Participants Who Achieved Bacterial Eradication at Visit 3 |
140; 148 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subject, of any race, who is at least 1 year of age.
- Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.
- The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.
- Must be willing to discontinue contact lens wear for the duration of the study.
Exclusion Criteria
- Any uncontrolled systemic disease or debilitating disease.
- Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.
- Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during study.
- Any active upper respiratory tract infection.
- Pregnant or nursing females.
- Use of any antibiotic (topical or systemic) within 72 hours of enrollment.
Data sourced from ClinicalTrials.gov (NCT00105469). 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.