Trial Outcomes & Findings for Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis (NCT NCT01740388)
NCT ID: NCT01740388
Last Updated: 2014-10-01
Results Overview
Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
136 participants
Primary outcome timeframe
Visit 2 (Day 4 or 5)
Results posted on
2014-10-01
Participant Flow
Participant milestones
| Measure |
Besifloxacin
besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
|
Vehicle
vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
72
|
|
Overall Study
COMPLETED
|
18
|
28
|
|
Overall Study
NOT COMPLETED
|
46
|
44
|
Reasons for withdrawal
| Measure |
Besifloxacin
besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
|
Vehicle
vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
2
|
6
|
|
Overall Study
Subjects missing data, completed
|
41
|
36
|
Baseline Characteristics
Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis
Baseline characteristics by cohort
| Measure |
Besifloxacin
n=64 Participants
besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
|
Vehicle
n=72 Participants
vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 22.52 • n=39 Participants
|
50.6 years
STANDARD_DEVIATION 21.36 • n=41 Participants
|
47.8 years
STANDARD_DEVIATION 22.03 • n=35 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=39 Participants
|
44 Participants
n=41 Participants
|
88 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
48 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=39 Participants
|
56 Participants
n=41 Participants
|
107 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (Day 4 or 5)Population: Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF \[Last Observation Carried Forward\])
Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Outcome measures
| Measure |
Besifloxacin
n=18 Participants
besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
|
Vehicle
n=28 Participants
vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.
|
|---|---|---|
|
Clinical Resolution
YES
|
4 participants
|
5 participants
|
|
Clinical Resolution
NO
|
14 participants
|
23 participants
|
PRIMARY outcome
Timeframe: Visit 2 (Day 4 or 5)Population: Analysis population is only Subjects with non-missing data, Microbial Eradication (LOCF \[Last Observation Carried Forward\])
Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Outcome measures
| Measure |
Besifloxacin
n=18 Participants
besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
|
Vehicle
n=28 Participants
vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.
|
|---|---|---|
|
Microbial Eradication
YES
|
17 participants
|
13 participants
|
|
Microbial Eradication
NO
|
1 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 6, 7, or 8)Population: Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF \[Last Observation Carried Forward\])
Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Outcome measures
| Measure |
Besifloxacin
n=18 Participants
besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
|
Vehicle
n=28 Participants
vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.
|
|---|---|---|
|
Clinical Resolution
YES
|
6 participants
|
13 participants
|
|
Clinical Resolution
NO
|
12 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 6, 7, or 8)Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Outcome measures
| Measure |
Besifloxacin
n=18 Participants
besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
|
Vehicle
n=28 Participants
vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.
|
|---|---|---|
|
Microbial Eradication
YES
|
14 participants
|
16 participants
|
|
Microbial Eradication
NO
|
4 participants
|
12 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At each follow-up visit (Visit 1, Visit 2 and Visit 3)Population: Analysis population is only Subjects with non-missing data, Ocular Discharge Evaluated on the Baseline-Designated Study Eye
Ocular conjunctival discharge measures on a scale of 0-3 where 0 = Absent, 1 = Mild, 2 = Moderate and 3 = Severe
Outcome measures
| Measure |
Besifloxacin
n=18 Participants
besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
|
Vehicle
n=28 Participants
vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.
|
|---|---|---|
|
Ocular Conjunctival Discharge
Visit 1: Absent
|
0 participants
|
0 participants
|
|
Ocular Conjunctival Discharge
Visit 1: Mild
|
6 participants
|
9 participants
|
|
Ocular Conjunctival Discharge
Visit 1: Moderate
|
10 participants
|
16 participants
|
|
Ocular Conjunctival Discharge
Visit 1: Severe
|
2 participants
|
3 participants
|
|
Ocular Conjunctival Discharge
Visit 2: Absent
|
9 participants
|
10 participants
|
|
Ocular Conjunctival Discharge
Visit 2: Mild
|
8 participants
|
15 participants
|
|
Ocular Conjunctival Discharge
Visit 2: Moderate
|
1 participants
|
2 participants
|
|
Ocular Conjunctival Discharge
Visit 2: Severe
|
0 participants
|
0 participants
|
|
Ocular Conjunctival Discharge
Visit 3: Absent
|
14 participants
|
16 participants
|
|
Ocular Conjunctival Discharge
Visit 3: Mild
|
4 participants
|
5 participants
|
|
Ocular Conjunctival Discharge
Visit 3: Moderate
|
0 participants
|
3 participants
|
|
Ocular Conjunctival Discharge
Visit 3: Severe
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At each follow-up visit (Visit 1, Visit 2 and Visit 3)Bulbar conjunctival injection measured on a scale of 0-3 where 0 = Normal, 1 = Mild, 2 = Moderate and 3 = Severe
Outcome measures
| Measure |
Besifloxacin
n=18 Participants
besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
|
Vehicle
n=28 Participants
vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.
|
|---|---|---|
|
Bulbar Conjunctival Injection
Visit 2: Severe
|
0 participants
|
0 participants
|
|
Bulbar Conjunctival Injection
Visit 1: Normal
|
0 participants
|
0 participants
|
|
Bulbar Conjunctival Injection
Visit 1: Mild
|
3 participants
|
6 participants
|
|
Bulbar Conjunctival Injection
Visit 1: Moderate
|
14 participants
|
18 participants
|
|
Bulbar Conjunctival Injection
Visit 1: Severe
|
1 participants
|
4 participants
|
|
Bulbar Conjunctival Injection
Visit 2: Normal
|
4 participants
|
7 participants
|
|
Bulbar Conjunctival Injection
Visit 2: Mild
|
13 participants
|
12 participants
|
|
Bulbar Conjunctival Injection
Visit 2: Moderate
|
1 participants
|
8 participants
|
|
Bulbar Conjunctival Injection
Visit 3: Normal
|
7 participants
|
12 participants
|
|
Bulbar Conjunctival Injection
Visit 3: Mild
|
11 participants
|
6 participants
|
|
Bulbar Conjunctival Injection
Visit 3: Moderate
|
0 participants
|
5 participants
|
|
Bulbar Conjunctival Injection
Visit 3: Severe
|
0 participants
|
1 participants
|
Adverse Events
Besifloxacin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Besifloxacin
n=64 participants at risk
besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
|
Vehicle
n=72 participants at risk
vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
3.1%
2/64 • Number of events 2
|
1.4%
1/72 • Number of events 1
|
|
Eye disorders
Eye Pain
|
0.00%
0/64
|
2.8%
2/72 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60