Trial Outcomes & Findings for Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis (NCT NCT00705159)

Results Overview

Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

137 participants

Primary outcome timeframe

Baseline to 15 days

Results posted on

2015-03-24

Participant Flow

This study was conducted at 17 sites in the United States. First participant was enrolled on 6/26/2008 and last participant visit was 3/24/2010.

A total of 137 pediatric subjects, 0 to 6 years of age, of either gender and any race, who had a clinical diagnosis of blepharoconjunctivitis in at least one eye were randomized in this study. 126 Participants completed the study.

Participant milestones

Participant milestones
Measure	Loteprednol Etabonate and Tobramycin Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).	Loteprednol Etabonate Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).	Tobramycin Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).	Vehicle Vehicle of Zylet. One or two drops in study eye four times a day (QID).
Overall Study STARTED	34	35	34	34
Overall Study COMPLETED	34	33	29	30
Overall Study NOT COMPLETED	0	2	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Loteprednol Etabonate Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).	Tobramycin Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).	Vehicle Vehicle of Zylet. One or two drops in study eye four times a day (QID).
Overall Study Withdrawal by Subject	1	1	1
Overall Study Protocol Violation	1	0	0
Overall Study Adverse Event	0	1	0
Overall Study Lost to Follow-up	0	3	2
Overall Study Screen Failure	0	0	1

Baseline Characteristics

Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Loteprednol Etabonate and Tobramycin n=34 Participants Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).	Loteprednol Etabonate n=35 Participants Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).	Tobramycin n=34 Participants Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).	Vehicle n=34 Participants Vehicle of Zylet. One or two drops in study eye four times a day (QID).	Total n=137 Participants Total of all reporting groups
Age, Customized 0-6 years	34 participants n=5 Participants	35 participants n=7 Participants	34 participants n=5 Participants	34 participants n=4 Participants	137 participants n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	14 Participants n=4 Participants	57 Participants n=21 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	20 Participants n=4 Participants	80 Participants n=21 Participants
Region of Enrollment United States	34 participants n=5 Participants	35 participants n=7 Participants	34 participants n=5 Participants	34 participants n=4 Participants	137 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline to 15 days

Population: Study eye, ITT Population, Non-missing data

Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.

Outcome measures

Outcome measures
Measure	Loteprednol Etabonate and Tobramycin n=34 Participants Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).	Loteprednol Etabonate n=35 Participants Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).	Tobramycin n=34 Participants Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).	Vehicle n=33 Participants Vehicle of Zylet. One or two drops in study eye four times a day (QID).
Change From Baseline in the Total Blepharoconjunctivitis Grade.	-11.41 Score on a scale Standard Deviation 3.29	-11.23 Score on a scale Standard Deviation 3.98	-10.68 Score on a scale Standard Deviation 4.71	-10.30 Score on a scale Standard Deviation 5.19

SECONDARY outcome

Timeframe: Baseline to Day 3

Population: Study eye, ITT population, non-missing data

Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.

Outcome measures

Outcome measures
Measure	Loteprednol Etabonate and Tobramycin n=34 Participants Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).	Loteprednol Etabonate n=34 Participants Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).	Tobramycin n=32 Participants Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).	Vehicle n=31 Participants Vehicle of Zylet. One or two drops in study eye four times a day (QID).
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2	-7.32 Score on a scale Standard Deviation 3.27	-7.74 Score on a scale Standard Deviation 3.90	-5.94 Score on a scale Standard Deviation 4.00	-6.58 Score on a scale Standard Deviation 3.46

SECONDARY outcome

Timeframe: Baseline to Day 7

Population: Study eye ITT population, subjects with non-missing data

Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.

Outcome measures

Outcome measures
Measure	Loteprednol Etabonate and Tobramycin n=34 Participants Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).	Loteprednol Etabonate n=34 Participants Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).	Tobramycin n=30 Participants Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).	Vehicle n=30 Participants Vehicle of Zylet. One or two drops in study eye four times a day (QID).
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3	-11.03 Score on a scale Standard Deviation 3.20	-10.94 Score on a scale Standard Deviation 4.69	-9.90 Score on a scale Standard Deviation 3.80	-10.03 Score on a scale Standard Deviation 4.63

Adverse Events

Loteprednol Etabonate and Tobramycin

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Loteprednol Etabonate

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Tobramycin

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Vehicle

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Loteprednol Etabonate and Tobramycin n=34 participants at risk Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).	Loteprednol Etabonate n=35 participants at risk Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).	Tobramycin n=34 participants at risk Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).	Vehicle n=33 participants at risk Vehicle of Zylet. One or two drops in study eye four times a day (QID).
Infections and infestations Respiratory distress	2.9% 1/34 • Number of events 1 • 15 days Safety population	2.9% 1/35 • Number of events 1 • 15 days Safety population	2.9% 1/34 • Number of events 1 • 15 days Safety population	3.0% 1/33 • Number of events 1 • 15 days Safety population
Infections and infestations Bronchiolitis	5.9% 2/34 • Number of events 2 • 15 days Safety population	5.7% 2/35 • Number of events 2 • 15 days Safety population	2.9% 1/34 • Number of events 2 • 15 days Safety population	3.0% 1/33 • Number of events 2 • 15 days Safety population

Other adverse events

Other adverse events
Measure	Loteprednol Etabonate and Tobramycin n=34 participants at risk Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).	Loteprednol Etabonate n=35 participants at risk Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).	Tobramycin n=34 participants at risk Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).	Vehicle n=33 participants at risk Vehicle of Zylet. One or two drops in study eye four times a day (QID).
Respiratory, thoracic and mediastinal disorders Cough	5.9% 2/34 • Number of events 2 • 15 days Safety population	5.7% 2/35 • Number of events 2 • 15 days Safety population	5.9% 2/34 • Number of events 2 • 15 days Safety population	6.1% 2/33 • Number of events 2 • 15 days Safety population

Additional Information

Tuyen Ong, MD, MRCOphth

Bausch & Lomb Incorporated

Phone: (973) 360-6389

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
Publication restrictions are in place

Restriction type: OTHER