Trial Outcomes & Findings for A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis (NCT NCT00348348)
NCT ID: NCT00348348
Last Updated: 2015-03-24
Results Overview
Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1161 participants
Primary outcome timeframe
Day 5(+/- 1 day)
Results posted on
2015-03-24
Participant Flow
This study was conducted at 84 sites in the US and Asia. First subject was enrolled 6/6/06, and last subject visit was 7/13/07.
1161 participants were randomized of which 533 had culture confirmed bacterial conjunctivitis.
Participant milestones
| Measure |
Moxifloxacin Solution
Moxifloxacin hydrochloride ophthalmic solution 0.5%
|
Besifloxacin Suspension
Besifloxacin ophthalmic suspension 0.6%
|
|---|---|---|
|
Overall Study
STARTED
|
579
|
582
|
|
Overall Study
COMPLETED
|
554
|
555
|
|
Overall Study
NOT COMPLETED
|
25
|
27
|
Reasons for withdrawal
| Measure |
Moxifloxacin Solution
Moxifloxacin hydrochloride ophthalmic solution 0.5%
|
Besifloxacin Suspension
Besifloxacin ophthalmic suspension 0.6%
|
|---|---|---|
|
Overall Study
Adverse event - unrelated to study drug
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
10
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Other
|
7
|
4
|
|
Overall Study
Dissallowed Meds - unrelated to study
|
1
|
3
|
|
Overall Study
Dissallowed Meds - unlikley related
|
1
|
1
|
|
Overall Study
Dissallowed Meds - possibly releated
|
1
|
1
|
|
Overall Study
Worsening of BC - Unrelated to study
|
0
|
3
|
|
Overall Study
Worsening of BC - Unlikely related
|
1
|
2
|
|
Overall Study
Adverse event probably related to study
|
1
|
0
|
Baseline Characteristics
A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis
Baseline characteristics by cohort
| Measure |
Moxifloxacin Solution
n=579 Participants
Moxifloxacin hydrochloride ophthalmic solution 0.5%
|
Besifloxacin Suspension
n=582 Participants
Besifloxacin ophthalmic suspension 0.6%
|
Total
n=1161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<2 years
|
15 participants
n=5 Participants
|
22 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Age, Customized
2 to 9 years
|
90 participants
n=5 Participants
|
91 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
Age, Customized
10 to 19 years
|
81 participants
n=5 Participants
|
75 participants
n=7 Participants
|
156 participants
n=5 Participants
|
|
Age, Customized
20 to 29 years
|
73 participants
n=5 Participants
|
93 participants
n=7 Participants
|
166 participants
n=5 Participants
|
|
Age, Customized
30 to 39 years
|
76 participants
n=5 Participants
|
71 participants
n=7 Participants
|
147 participants
n=5 Participants
|
|
Age, Customized
40 to 49 years
|
59 participants
n=5 Participants
|
68 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Age, Customized
50 to 59 years
|
65 participants
n=5 Participants
|
63 participants
n=7 Participants
|
128 participants
n=5 Participants
|
|
Age, Customized
>/= 60 years
|
120 participants
n=5 Participants
|
99 participants
n=7 Participants
|
219 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
323 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
655 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
256 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
506 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
89 participants
n=5 Participants
|
87 participants
n=7 Participants
|
176 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
63 participants
n=5 Participants
|
73 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
391 participants
n=5 Participants
|
385 participants
n=7 Participants
|
776 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 5(+/- 1 day)Population: modified intent to treat (mITT), culture confirmed, as treated
Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
Outcome measures
| Measure |
Moxifloxacin Solution
n=281 Participants
Moxifloxacin hydrochloride ophthalmic solution 0.5%
|
Besifloxacin Suspension
n=252 Participants
Besifloxacin ophthalmic suspension 0.6%
|
|---|---|---|
|
Clinical Resolution
|
167 Participants
|
147 Participants
|
PRIMARY outcome
Timeframe: Day 5 (+/- 1 day)Population: modified intent to treat (mITT), culture confirmed, as treated
eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Outcome measures
| Measure |
Moxifloxacin Solution
n=281 Participants
Moxifloxacin hydrochloride ophthalmic solution 0.5%
|
Besifloxacin Suspension
n=252 Participants
Besifloxacin ophthalmic suspension 0.6%
|
|---|---|---|
|
Microbial Eradication
|
256 Participants
|
235 Participants
|
SECONDARY outcome
Timeframe: Day 8 or Day 9Population: modified intent to treat (mITT), culture confirmed, as treated
Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated
Outcome measures
| Measure |
Moxifloxacin Solution
n=281 Participants
Moxifloxacin hydrochloride ophthalmic solution 0.5%
|
Besifloxacin Suspension
n=252 Participants
Besifloxacin ophthalmic suspension 0.6%
|
|---|---|---|
|
Clinical Resolution
|
236 Participants
|
213 Participants
|
SECONDARY outcome
Timeframe: Day 8 or Day 9Population: modified intent to treat (mITT), culture confirmed, as treated
Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Outcome measures
| Measure |
Moxifloxacin Solution
n=281 Participants
Moxifloxacin hydrochloride ophthalmic solution 0.5%
|
Besifloxacin Suspension
n=252 Participants
Besifloxacin ophthalmic suspension 0.6%
|
|---|---|---|
|
Microbial Eradication
|
238 Participants
|
220 Participants
|
Adverse Events
Moxifloxacin Solution
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Besifloxacin Suspension
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Moxifloxacin Solution
n=855 participants at risk；n=579 participants at risk
Moxifloxacin hydrochloride ophthalmic solution 0.5%
|
Besifloxacin Suspension
n=865 participants at risk；n=582 participants at risk
Besifloxacin ophthalmic suspension 0.6%
|
|---|---|---|
|
Infections and infestations
Acute viral syndrome
|
0.17%
1/579 • Number of events 1 • Participants were treated three times daily for 5 days
Safety population - All treated eyes
|
0.17%
1/582 • Number of events 1 • Participants were treated three times daily for 5 days
Safety population - All treated eyes
|
|
Cardiac disorders
Congestive heart failure
|
0.17%
1/579 • Number of events 1 • Participants were treated three times daily for 5 days
Safety population - All treated eyes
|
0.17%
1/582 • Number of events 1 • Participants were treated three times daily for 5 days
Safety population - All treated eyes
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has 45 days to review materials and provide comments back to the investigator.
- Publication restrictions are in place
Restriction type: OTHER