Trial Outcomes & Findings for Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis (NCT NCT00759148)
NCT ID: NCT00759148
Last Updated: 2018-01-02
Results Overview
Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.
COMPLETED
PHASE3
1179 participants
Day 4
2018-01-02
Participant Flow
Subjects were recruited from 108 study centers located in the US.
1179 subjects with bacterial conjunctivitis were randomized and treated to Moxifloxacin AF or Moxifloxacin AF vehicle.
Participant milestones
| Measure |
Moxifloxacin AF
Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
|
Vehicle
Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
|
|---|---|---|
|
Overall Study
STARTED
|
593
|
586
|
|
Overall Study
COMPLETED
|
579
|
554
|
|
Overall Study
NOT COMPLETED
|
14
|
32
|
Reasons for withdrawal
| Measure |
Moxifloxacin AF
Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
|
Vehicle
Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
|
Overall Study
Lost to Follow-up
|
3
|
9
|
|
Overall Study
Treatment Failure
|
6
|
10
|
|
Overall Study
Reason not given
|
1
|
0
|
Baseline Characteristics
Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis
Baseline characteristics by cohort
| Measure |
Moxifloxacin AF
n=593 Participants
Moxifloxacin AF Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
|
Vehicle
n=586 Participants
Moxifloxacin AF Vehicle, 1 drop in each eye twice daily for 3 days
|
Total
n=1179 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
49 Participants
n=39 Participants
|
47 Participants
n=41 Participants
|
96 Participants
n=35 Participants
|
|
Age, Customized
Children (2-11 years)
|
174 Participants
n=39 Participants
|
184 Participants
n=41 Participants
|
358 Participants
n=35 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
71 Participants
n=39 Participants
|
72 Participants
n=41 Participants
|
143 Participants
n=35 Participants
|
|
Age, Customized
Adults (18-64 years)
|
257 Participants
n=39 Participants
|
230 Participants
n=41 Participants
|
487 Participants
n=35 Participants
|
|
Age, Customized
From 65-84 years
|
38 Participants
n=39 Participants
|
48 Participants
n=41 Participants
|
86 Participants
n=35 Participants
|
|
Age, Customized
85 years and over
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
353 Participants
n=39 Participants
|
338 Participants
n=41 Participants
|
691 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
240 Participants
n=39 Participants
|
248 Participants
n=41 Participants
|
488 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 4Population: This analysis population includes all patients who received drug, had at least 1 on-therapy visit and were pathogen positive for bacteria on Day 1 (Microbiological Intent-to-Treat (MBITT) Analysis Set).
Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Moxifloxacin AF
n=424 Participants
Moxifloxacin AF Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
|
Vehicle
n=423 Participants
Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
|
|---|---|---|
|
Clinical Cure at the Day 4 (EOT)/Exit Visit
|
62.5 percentage of subjects
|
50.6 percentage of subjects
|
SECONDARY outcome
Timeframe: Day 4Population: MBITT Analysis Set
Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Moxifloxacin AF
n=424 Participants
Moxifloxacin AF Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
|
Vehicle
n=423 Participants
Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
|
|---|---|---|
|
Microbiological Success at the Day 4 (EOT)/Exit Visit
|
74.5 percentage of subjects
|
56 percentage of subjects
|
Adverse Events
Moxifloxacin AF
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 Sponsor reserves the right to review study related information prior to presentation or publication.
- Publication restrictions are in place
Restriction type: OTHER