Trial Outcomes & Findings for Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004) (NCT NCT00105469)
NCT ID: NCT00105469
Last Updated: 2013-12-16
Results Overview
Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).
COMPLETED
PHASE3
743 participants
Visit 3 (Day 6)
2013-12-16
Participant Flow
Participant milestones
| Measure |
AzaSite
|
Tobramycin
|
|---|---|---|
|
Overall Study
STARTED
|
365
|
378
|
|
Overall Study
COMPLETED
|
343
|
367
|
|
Overall Study
NOT COMPLETED
|
22
|
11
|
Reasons for withdrawal
| Measure |
AzaSite
|
Tobramycin
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
8
|
|
Overall Study
Protocol Violation
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Other Reason
|
4
|
0
|
Baseline Characteristics
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
Baseline characteristics by cohort
| Measure |
AzaSite
n=159 Participants
Per protocol population (defined as all randomized
subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of
pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.
|
Tobramycin
n=157 Participants
Per protocol population (defined as all randomized
subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of
pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.
|
Total
n=316 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.9 years
STANDARD_DEVIATION 20.23 • n=5 Participants
|
22.8 years
STANDARD_DEVIATION 22.61 • n=7 Participants
|
20.4 years
STANDARD_DEVIATION 21.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 3 (Day 6)Population: Per protocol population (defined as all randomized subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.
Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).
Outcome measures
| Measure |
AzaSite
n=159 Participants
|
Tobramycin
n=157 Participants
|
|---|---|---|
|
Number of Participants Who Achieved Clinical Resolution at Visit 3
|
127 Participants
|
123 Participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 6)Population: Per protocol population (defined as all randomized subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.
Bacterial eradication is defined as eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).
Outcome measures
| Measure |
AzaSite
n=159 Participants
|
Tobramycin
n=157 Participants
|
|---|---|---|
|
Number of Participants Who Achieved Bacterial Eradication at Visit 3
|
140 Participants
|
148 Participants
|
Adverse Events
AzaSite
Tobramycin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and Principal Investigator shall not publish, present or use any data or results arising out of the performance of this study for their own instruction, research or publication without the prior express written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER