Trial Outcomes & Findings for Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis (NCT NCT01330355)
NCT ID: NCT01330355
Last Updated: 2014-09-03
Results Overview
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
33 participants
Primary outcome timeframe
Visit 5 (Day 8+1)
Results posted on
2014-09-03
Participant Flow
Participant milestones
| Measure |
Besivance
Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
|
Gatifloxacin
Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis
Baseline characteristics by cohort
| Measure |
Besivance
n=16 Participants
Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
|
Gatifloxacin
n=17 Participants
Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
17 days
n=5 Participants
|
14 days
n=7 Participants
|
14 days
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 5 (Day 8+1)Population: The analysis population only includes those for whom the outcome was measured within the specified time frame.
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Outcome measures
| Measure |
Besivance
n=16 Participants
Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
|
Gatifloxacin
n=16 Participants
Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
|
|---|---|---|
|
Clinical Resolution
|
12 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 3)Population: The analysis population only includes those for whom the outcome was measured within the specified time frame.
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Outcome measures
| Measure |
Besivance
n=16 Participants
Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
|
Gatifloxacin
n=16 Participants
Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
|
|---|---|---|
|
Clinical Resolution
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Visit 5 (Day 8+1)Population: The analysis population only includes those for whom the outcome was measured within the specified time frame.
Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline
Outcome measures
| Measure |
Besivance
n=13 Participants
Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
|
Gatifloxacin
n=9 Participants
Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
|
|---|---|---|
|
Microbial Eradication
|
12 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Visit 3 (Day 3) and Visit 5 (Day 8+1)Population: The analysis population only includes those for whom the outcome was measured within the specified time frame. A subject may have tested positive for multiple bacterial species (up to 5 species).
Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline: * over all bacterial species * over all and individual gram-positive bacterial species * over all and individual gram-negative bacterial species
Outcome measures
| Measure |
Besivance
n=13 Participants
Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
|
Gatifloxacin
n=9 Participants
Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
|
|---|---|---|
|
Microbial Outcome
Visit 3 (Day 3) Gram-Positive
|
16 events
|
6 events
|
|
Microbial Outcome
Visit 3 (Day 3) Gram-Negative
|
6 events
|
3 events
|
|
Microbial Outcome
Visit 5 (Day 8) Gram-Positive
|
17 events
|
12 events
|
|
Microbial Outcome
Visit 5 (Day8) Gram-Negative
|
6 events
|
4 events
|
Adverse Events
Besivance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gatifloxacin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Besivance
n=16 participants at risk
Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
|
Gatifloxacin
n=17 participants at risk
Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
|
|---|---|---|
|
Eye disorders
Conjunctivitis Bacterial
|
0.00%
0/16 • The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
|
5.9%
1/17 • Number of events 1 • The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/16 • The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
|
5.9%
1/17 • Number of events 1 • The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/16 • The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
|
5.9%
1/17 • Number of events 1 • The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
|
5.9%
1/17 • Number of events 1 • The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
|
|
Skin and subcutaneous tissue disorders
Acne Infantile
|
0.00%
0/16 • The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
|
5.9%
1/17 • Number of events 1 • The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/16 • The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
|
5.9%
1/17 • Number of events 1 • The period of observation for collection of AEs extended from the time the subject's parent/legally authorized representative provided informed consent until the last study visit, Visit 5.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee For a period of ten years, the PI agrees to keep confidential and not disclose, without the prior written consent of Sponsor, to any third party or use any technology, data, reports, results of clinical studies conducted under this Study or other information received by Sponsor, or any technology, data, reports, study materials, or other information developed by Sponsor unless disclosure by PI is required by law.
- Publication restrictions are in place
Restriction type: OTHER