Trial Outcomes & Findings for Pediatric Zylet Safety and Efficacy Study (NCT NCT00420628)
NCT ID: NCT00420628
Last Updated: 2011-10-07
Results Overview
Study eye - Safety Population, At all visits 1,2,3
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
108 participants
Primary outcome timeframe
day 1, day 8, day 15
Results posted on
2011-10-07
Participant Flow
108 subjects aged 0-6 years with lid inflammation were recruited from 15 clinic locations in the US. First subject was enrolled on 11/07/2006, last subject visit was 1/5/2009.
108 subjects were randomized to receive loteprednol/tobramycin or its vehicle in a 2:1 ratio. Subjects will receive warm compress lid treatment 2 times daily, before administration of study medication (as applicable) for the 14-day treatment duration.
Participant milestones
| Measure |
Loteprednol/Tobramycin
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
|
Vehicle
Vehicle used in the study drug administered into affected eye(s) for 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
36
|
|
Overall Study
COMPLETED
|
63
|
32
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
Loteprednol/Tobramycin
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
|
Vehicle
Vehicle used in the study drug administered into affected eye(s) for 14 days
|
|---|---|---|
|
Overall Study
Withdrawn by parent or gaurdian
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Pediatric Zylet Safety and Efficacy Study
Baseline characteristics by cohort
| Measure |
Loteprednol/Tobramycin
n=72 Participants
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
|
Vehicle
n=36 Participants
Vehicle used in the study drug administered into affected eye(s) for 14 days
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age 0-6 years
|
72 participants
n=5 Participants
|
36 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
52 participants
n=5 Participants
|
25 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: day 1, day 8, day 15Population: Safety population, Study eye
Study eye - Safety Population, At all visits 1,2,3
Outcome measures
| Measure |
Loteprednol/Tobramycin
n=72 Participants
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
|
Vehicle
n=36 Participants
Vehicle used in the study drug administered into affected eye(s) for 14 days
|
|---|---|---|
|
Treatment Emergent Adverse Events
Conjunctivitis
|
2 participants
|
0 participants
|
|
Treatment Emergent Adverse Events
Meibomianitis
|
1 participants
|
1 participants
|
|
Treatment Emergent Adverse Events
Eyelid edema
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Visit 3, day 8Population: Efficacy Sample, subjects with non-missing data. Day 15 (Visit 3)
The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened.
Outcome measures
| Measure |
Loteprednol/Tobramycin
n=63 Participants
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
|
Vehicle
n=32 Participants
Vehicle used in the study drug administered into affected eye(s) for 14 days
|
|---|---|---|
|
Investigators Global Assessment of the Clinical Condition
Improved
|
36 Participants
Interval 44.0 to 69.5
|
17 Participants
Interval 34.7 to 70.9
|
|
Investigators Global Assessment of the Clinical Condition
Unchanged
|
25 Participants
|
13 Participants
|
|
Investigators Global Assessment of the Clinical Condition
Worse
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (day 1)Population: Efficacy sample, non-missing data
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Outcome measures
| Measure |
Loteprednol/Tobramycin
n=66 Participants
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
|
Vehicle
n=34 Participants
Vehicle used in the study drug administered into affected eye(s) for 14 days
|
|---|---|---|
|
Assessment of Ocular Signs in the Study Eye - Visit 1
Lid Edema
|
1.97 Units on a scale 0-4
Standard Deviation 0.84
|
2.06 Units on a scale 0-4
Standard Deviation 0.95
|
|
Assessment of Ocular Signs in the Study Eye - Visit 1
Lid Erythema
|
1.98 Units on a scale 0-4
Standard Deviation 1.10
|
1.82 Units on a scale 0-4
Standard Deviation 1.22
|
|
Assessment of Ocular Signs in the Study Eye - Visit 1
Palpebral Conjunctival Injection
|
1.85 Units on a scale 0-4
Standard Deviation 1.13
|
1.79 Units on a scale 0-4
Standard Deviation 0.98
|
|
Assessment of Ocular Signs in the Study Eye - Visit 1
Meibomian Plugging
|
1.44 Units on a scale 0-4
Standard Deviation 1.04
|
1.59 Units on a scale 0-4
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Visit 2 (day 8)Population: Efficacy population - Study eye
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Outcome measures
| Measure |
Loteprednol/Tobramycin
n=66 Participants
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
|
Vehicle
n=32 Participants
Vehicle used in the study drug administered into affected eye(s) for 14 days
|
|---|---|---|
|
Assessment of Ocular Signs in the Study Eye - Visit 2
Meibomian Plugging
|
1.06 Units on a scale 0-4
Standard Deviation 1.02
|
1.00 Units on a scale 0-4
Standard Deviation 1.11
|
|
Assessment of Ocular Signs in the Study Eye - Visit 2
Lid Edema
|
1.47 Units on a scale 0-4
Standard Deviation 0.92
|
1.38 Units on a scale 0-4
Standard Deviation 0.94
|
|
Assessment of Ocular Signs in the Study Eye - Visit 2
Lid Erythema
|
1.41 Units on a scale 0-4
Standard Deviation 1.01
|
1.47 Units on a scale 0-4
Standard Deviation 1.08
|
|
Assessment of Ocular Signs in the Study Eye - Visit 2
Palpebral Conjunctival Injection
|
1.41 Units on a scale 0-4
Standard Deviation 1.01
|
1.16 Units on a scale 0-4
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Visit 3 (day 15)Population: Efficacy sample - Study eye
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Outcome measures
| Measure |
Loteprednol/Tobramycin
n=63 Participants
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
|
Vehicle
n=32 Participants
Vehicle used in the study drug administered into affected eye(s) for 14 days
|
|---|---|---|
|
Assessment of Ocular Signs in the Study Eye - Visit 3
Lid Edema
|
1.03 Units on a scale 0-4
Standard Deviation 0.90
|
1.41 Units on a scale 0-4
Standard Deviation 1.10
|
|
Assessment of Ocular Signs in the Study Eye - Visit 3
Lid Erythema
|
1.00 Units on a scale 0-4
Standard Deviation 0.88
|
1.50 Units on a scale 0-4
Standard Deviation 1.14
|
|
Assessment of Ocular Signs in the Study Eye - Visit 3
Palpebral Conjunctival Injection
|
1.11 Units on a scale 0-4
Standard Deviation 0.95
|
1.09 Units on a scale 0-4
Standard Deviation 1.09
|
|
Assessment of Ocular Signs in the Study Eye - Visit 3
Meibomian Plugging
|
0.86 Units on a scale 0-4
Standard Deviation 1.12
|
1.16 Units on a scale 0-4
Standard Deviation 1.22
|
Adverse Events
Loteprednol/Tobramycin
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Loteprednol/Tobramycin
n=72 participants at risk
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
|
Vehicle
n=36 participants at risk
Vehicle used in the study drug administered into affected eye(s) for 14 days
|
|---|---|---|
|
Vascular disorders
bilateral subdural hematoma
|
1.4%
1/72 • Number of events 1 • 14 days
|
0.00%
0/36 • 14 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of the study may be published or presented by the investigator(s) after the review by, and in consultation and agreement with Bausch \& Lomb, and such that confidential or proprietary information is not disclosed. Prior to publication or presentation, a copy of the final text should be forwarded by the investigator(s) to Bausch \& Lomb or its designee, for comment.
- Publication restrictions are in place
Restriction type: OTHER