Clinical trial NCT01175590: Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
Official title: A Study to Evaluate the Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle Following Three Times Daily(TID) Dosing for 7 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Conjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-08-05
Enrollment: 518
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.


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.

Primary outcomes:
measure: Ocular Treatment Emergent Adverse Events
timeFrame: At each visit - 7 days
measure: Non-Ocular Treatment-Emergent Adverse Events
timeFrame: 7 days
Secondary outcomes:
measure: Clinical Resolution
timeFrame: Day 8 (Visit 2)
measure: Clinical Resolution
timeFrame: Day 11 (Visit 3)
measure: Microbial Eradication
timeFrame: Days 8 (Visit 2)
measure: Microbial Eradication
timeFrame: Days 11 (Visit 3)
measure: Microbial Outcome With Clinical Resolution
timeFrame: Day 8 (Visit 2)
measure: Microbial Outcome With Clinical Resolution
timeFrame: Day 11 (Visit 3)
measure: Individual Clinical Outcomes - Ocular Discharge
timeFrame: At day 1 (Vist 1)
measure: Individual Clinical Outcomes - Ocular Discharge
timeFrame: At day 8 (Vist 2)
measure: Individual Clinical Outcomes - Ocular Discharge
timeFrame: At day 11 (Vist 3)
measure: Individual Clinical Outcomes - Bulbar Injection
timeFrame: At day 1 (Vist 1)
measure: Individual Clinical Outcomes - Bulbar Injection
timeFrame: At day 8 (Vist 2)
measure: Individual Clinical Outcomes - Bulbar Injection
timeFrame: At day 11 (Vist 3)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb, Inc.
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Catherine Allaire, MD
role: STUDY_DIRECTOR
References: