Trial Outcomes & Findings for Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis (NCT NCT00972777)
NCT ID: NCT00972777
Last Updated: 2012-03-29
Results Overview
The absence of both conjunctival discharge and bulbar conjunctival injection.
COMPLETED
PHASE2/PHASE3
474 participants
Visit 2
2012-03-29
Participant Flow
This was a two phase (IIB/III) integrated study. Phase IIb was conducted at 31 sites and Phase III at 28 sites in the United States. The first participant was enrolled in phase IIb on 10/30/2009, and last participant exited the study on 04/09/2010. Phase III enrolled its first participant on 04/05/2010 and last participant exited on 10/13/2010.
A total of 474 participants were enrolled in the integrated study in the intent to treat(ITT) population. 276 participants had culture confirmed bacterial conjunctivitis and were assigned to the modified intent to treat(mITT) population. 464 participants were assigned to the safety population. 446 participants completed the study.
Participant milestones
| Measure |
Besifloxacin
0.6% ophthalmic suspension
|
Vehicle
Vehicle of besifloxacin ophthalmic suspension
|
|---|---|---|
|
Overall Study
STARTED
|
231
|
243
|
|
Overall Study
COMPLETED
|
217
|
229
|
|
Overall Study
NOT COMPLETED
|
14
|
14
|
Reasons for withdrawal
| Measure |
Besifloxacin
0.6% ophthalmic suspension
|
Vehicle
Vehicle of besifloxacin ophthalmic suspension
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Physician Decision
|
4
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Screening Failure
|
2
|
1
|
|
Overall Study
Missed visit
|
1
|
0
|
Baseline Characteristics
Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis
Baseline characteristics by cohort
| Measure |
Besifloxacin
n=231 Participants
0.6% ophthalmic suspension
|
Vehicle
n=243 Participants
Vehicle of besifloxacin ophthalmic suspension
|
Total
n=474 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<2 years
|
14 participants
n=93 Participants
|
13 participants
n=4 Participants
|
27 participants
n=27 Participants
|
|
Age, Customized
2 - 11 years
|
66 participants
n=93 Participants
|
77 participants
n=4 Participants
|
143 participants
n=27 Participants
|
|
Age, Customized
12 - 17 years
|
19 participants
n=93 Participants
|
20 participants
n=4 Participants
|
39 participants
n=27 Participants
|
|
Age, Customized
18 - 29 years
|
32 participants
n=93 Participants
|
40 participants
n=4 Participants
|
72 participants
n=27 Participants
|
|
Age, Customized
30 - 39 years
|
21 participants
n=93 Participants
|
29 participants
n=4 Participants
|
50 participants
n=27 Participants
|
|
Age, Customized
40 - 49 years
|
23 participants
n=93 Participants
|
14 participants
n=4 Participants
|
37 participants
n=27 Participants
|
|
Age, Customized
50 - 59 years
|
20 participants
n=93 Participants
|
19 participants
n=4 Participants
|
39 participants
n=27 Participants
|
|
Age, Customized
>=60 years
|
35 participants
n=93 Participants
|
31 participants
n=4 Participants
|
66 participants
n=27 Participants
|
|
Age, Customized
Missing
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=93 Participants
|
133 Participants
n=4 Participants
|
275 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=93 Participants
|
110 Participants
n=4 Participants
|
199 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
7 participants
n=93 Participants
|
5 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=93 Participants
|
7 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
45 participants
n=93 Participants
|
58 participants
n=4 Participants
|
103 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
167 participants
n=93 Participants
|
166 participants
n=4 Participants
|
333 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=93 Participants
|
5 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Visit 2Population: Clinical Resolution at Visit 2, (LOCF), mITT Population.
The absence of both conjunctival discharge and bulbar conjunctival injection.
Outcome measures
| Measure |
Besifloxacin
n=135 Participants
0.6% ophthalmic suspension
|
Vehicle
n=141 Participants
Vehicle of besifloxacin ophthalmic suspension
|
|---|---|---|
|
Clinical Resolution
|
89 eyes
|
62 eyes
|
PRIMARY outcome
Timeframe: Visit 2Population: Microbial Eradication at Visit 2, (LOCF), mITT Population.
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
Outcome measures
| Measure |
Besifloxacin
n=135 Participants
0.6% ophthalmic suspension
|
Vehicle
n=141 Participants
Vehicle of besifloxacin ophthalmic suspension
|
|---|---|---|
|
Microbial Eradication
|
115 eyes
|
77 eyes
|
SECONDARY outcome
Timeframe: Visit 3Population: Clinical Resolution at Visit 3, (LOCF) mITT Population.
The absence of both conjunctival discharge and bulbar conjunctival injection.
Outcome measures
| Measure |
Besifloxacin
n=135 Participants
0.6% ophthalmic suspension
|
Vehicle
n=141 Participants
Vehicle of besifloxacin ophthalmic suspension
|
|---|---|---|
|
Clinical Resolution
|
103 eyes
|
94 eyes
|
SECONDARY outcome
Timeframe: Visit 3Population: Microbial Eradication at Visit 3, (LOCF), mITT Population.
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
Outcome measures
| Measure |
Besifloxacin
n=135 Participants
0.6% ophthalmic suspension
|
Vehicle
n=141 Participants
Vehicle of besifloxacin ophthalmic suspension
|
|---|---|---|
|
Microbial Eradication
|
115 eyes
|
91 eyes
|
Adverse Events
Besifloxacin
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
- Publication restrictions are in place
Restriction type: OTHER