Phase 3
Completed N=518
Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
Bacterial Conjunctivitis
Source: ClinicalTrials.gov NCT01175590 ↗
Enrolled (actual)
518
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Ocular Treatment Emergent Adverse Events — 3; 3; 1; 1 Events
Summary
The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Treatment Emergent Adverse Events |
3; 3; 1; 1; 1; 1 | — |
| PRIMARY Non-Ocular Treatment-Emergent Adverse Events |
1; 0; 1; 0; 1; 0 | — |
| SECONDARY Clinical Resolution |
169; 68 | — |
| SECONDARY Microbial Eradication |
169; 48 | — |
| SECONDARY Microbial Outcome With Clinical Resolution |
143; 42; 23; 25; 26; 6 | — |
| SECONDARY Individual Clinical Outcomes - Ocular Discharge |
187; 77; 12; 6; 4; 1 | — |
| SECONDARY Individual Clinical Outcomes - Bulbar Injection |
182; 72; 18; 11; 4; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye.
- Subjects who are willing to discontinue contact lens wear for the duration of the study.
- Subjects who are able and willing to comply with all treatment and follow- up/study procedures.
Exclusion Criteria
- Subjects who have any uncontrolled systemic disease or debilitating disease.
- Subjects with a known hypersensitivity or contraindications to Besivance, fluoroquinolones, or any of the ingredients in the study drugs.
- Subjects who are expected to require disallowed concurrent systemic or ocular therapy(either eye)during or prior to study start. (ie, NSAIDs, corticosteroids, mast cell stabilizers, antihistamines, decongestants or antimicrobial therapy)
- Subjects having ocular surgery (including laser surgery) in either eye within six weeks prior to entry into this study.
- Subjects with suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
- Subjects with suspected iritis.
- Subjects with a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
- Subjects with any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis.
- Subjects who are immune compromised.
Data sourced from ClinicalTrials.gov (NCT01175590). 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.