Trial Outcomes & Findings for Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003) (NCT NCT00105534)
NCT ID: NCT00105534
Last Updated: 2013-11-21
Results Overview
Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.
COMPLETED
PHASE3
685 participants
Visit 3 (Days 6-7)
2013-11-21
Participant Flow
Participant milestones
| Measure |
AzaSite
|
Vehicle
|
|---|---|---|
|
Overall Study
STARTED
|
335
|
350
|
|
Overall Study
COMPLETED
|
313
|
317
|
|
Overall Study
NOT COMPLETED
|
22
|
33
|
Reasons for withdrawal
| Measure |
AzaSite
|
Vehicle
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
5
|
|
Overall Study
Protocol Violation
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
|
Overall Study
Lack of Efficacy
|
7
|
15
|
|
Overall Study
Treatment unmasked
|
1
|
0
|
|
Overall Study
Other Reason
|
0
|
2
|
Baseline Characteristics
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
Baseline characteristics by cohort
| Measure |
AzaSite
n=130 Participants
Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.
|
Vehicle
n=149 Participants
Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.
|
Total
n=279 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
25.6 years
STANDARD_DEVIATION 24.49 • n=5 Participants
|
30.8 years
STANDARD_DEVIATION 28.07 • n=7 Participants
|
28.4 years
STANDARD_DEVIATION 26.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 3 (Days 6-7)Population: Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had 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=130 Participants
|
Vehicle
n=149 Participants
|
|---|---|---|
|
Participants Who Achieved Clinical Resolution
|
82 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 6-7)Population: Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.
Bacterial eradication is defined as the 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=130 Participants
|
Vehicle
n=149 Participants
|
|---|---|---|
|
Participants Who Achieved Bacteriological Eradication
|
115 Participants
|
99 Participants
|
Adverse Events
AzaSite
Vehicle
Serious adverse events
| Measure |
AzaSite
n=333 participants at risk
|
Vehicle
n=350 participants at risk
|
|---|---|---|
|
Eye disorders
Cornela Ulcer
|
0.00%
0/333
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/333
|
0.29%
1/350 • Number of events 1
|
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