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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00705159
• Collaborator: (none)
• Enrollment: 137
• Location: 1
• Arms: 4
• Duration (Months): 23
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.

Condition or Disease	Intervention/Treatment	Phase
Conjunctivitis	Drug: loteprednol etabonate and tobramycin; Drug: loteprednol etabonate; Drug: Tobramycin; Drug: Vehicle of Zylet	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 137 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Loteprednol etabonate and tobramycin Drug: Zylet (loteprednol etabonate and tobramycin)	Drug: loteprednol etabonate and tobramycin; Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.; Other Names: Zylet
Active Comparator: Loteprednol etabonate Drug: Lotemax (loteprednol etabonate)	Drug: loteprednol etabonate; Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.; Other Names: Lotemax
Active Comparator: Tobramycin Drug: Tobramycin	Drug: Tobramycin; Topical ocular administration of Tobramycin QID for 14 days.
Placebo Comparator: Vehicle Vehicle of Zylet	Drug: Vehicle of Zylet; Topical ocular administration of the vehicle of Zylet QID for 14 days.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in the Total Blepharoconjunctivitis Grade. [Baseline to 15 days]

   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.

Secondary Outcome Measures

1. Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2 [Baseline to Day 3]

   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.

2. Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3 [Baseline to Day 7]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Week to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• children 0-6 years of age.

• clinical diagnosis of blepharoconjunctivitis

• Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.

• Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.

Exclusion Criteria:

• Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.

• Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.

• Subjects who are monocular.

• Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.

• Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pediatric Ophthalmology of Erie	Erie	Pennsylvania	United States	16501

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00705159
• Other Study ID Numbers: 550
• First Posted: Jun 25, 2008
• Last Update Posted: Mar 24, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Bausch & Lomb Incorporated: Blepharokeratoconjunctivitis
• Additional relevant MeSH terms: Conjunctivitis; Loteprednol Etabonate; Tobramycin

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

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

Baseline Characteristics

Arm/Group Title	Loteprednol Etabonate and Tobramycin	Loteprednol Etabonate	Tobramycin	Vehicle	Total
Arm/Group Description	Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).	Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).	Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).	Vehicle of Zylet. One or two drops in study eye four times a day (QID).	Total of all reporting groups
Overall Participants	34	35	34	34	137
Age, Customized (participants) [Number]
0-6 years	34 100%	35 100%	34 100%	34 100%	137 100%
Sex: Female, Male (Count of Participants)
Female	10 29.4%	18 51.4%	15 44.1%	14 41.2%	57 41.6%
Male	24 70.6%	17 48.6%	19 55.9%	20 58.8%	80 58.4%
Region of Enrollment (participants) [Number]
United States	34 100%	35 100%	34 100%	34 100%	137 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in the Total Blepharoconjunctivitis Grade.
Description	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.
Time Frame	Baseline to 15 days

Outcome Measure Data

Analysis Population Description

Study eye, ITT Population, Non-missing data

Arm/Group Title	Loteprednol Etabonate and Tobramycin	Loteprednol Etabonate	Tobramycin	Vehicle
Arm/Group Description	Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).	Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).	Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).	Vehicle of Zylet. One or two drops in study eye four times a day (QID).
Measure Participants	34	35	34	33
Mean (Standard Deviation) [Score on a scale]	-11.41 (3.29)	-11.23 (3.98)	-10.68 (4.71)	-10.30 (5.19)

2. Secondary Outcome

Title	Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2
Description	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.
Time Frame	Baseline to Day 3

Outcome Measure Data

Analysis Population Description

Study eye, ITT population, non-missing data

Arm/Group Title	Loteprednol Etabonate and Tobramycin	Loteprednol Etabonate	Tobramycin	Vehicle
Arm/Group Description	Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).	Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).	Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).	Vehicle of Zylet. One or two drops in study eye four times a day (QID).
Measure Participants	34	34	32	31
Mean (Standard Deviation) [Score on a scale]	-7.32 (3.27)	-7.74 (3.90)	-5.94 (4.00)	-6.58 (3.46)

3. Secondary Outcome

Title	Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3
Description	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.
Time Frame	Baseline to Day 7

Outcome Measure Data

Analysis Population Description

Study eye ITT population, subjects with non-missing data

Arm/Group Title	Loteprednol Etabonate and Tobramycin	Loteprednol Etabonate	Tobramycin	Vehicle
Arm/Group Description	Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).	Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).	Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).	Vehicle of Zylet. One or two drops in study eye four times a day (QID).
Measure Participants	34	34	30	30
Mean (Standard Deviation) [Score on a scale]	-11.03 (3.20)	-10.94 (4.69)	-9.90 (3.80)	-10.03 (4.63)

Adverse Events

Time Frame	15 days
Adverse Event Reporting Description	Safety population
Arm/Group Title	Loteprednol Etabonate and Tobramycin		Loteprednol Etabonate		Tobramycin		Vehicle
Arm/Group Description	Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).		Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).		Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).		Vehicle of Zylet. One or two drops in study eye four times a day (QID).
All Cause Mortality
	Loteprednol Etabonate and Tobramycin		Loteprednol Etabonate		Tobramycin		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Loteprednol Etabonate and Tobramycin		Loteprednol Etabonate		Tobramycin		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/34 (5.9%)		2/35 (5.7%)		2/34 (5.9%)		1/33 (3%)
Infections and infestations
Respiratory distress	1/34 (2.9%)	1	1/35 (2.9%)	1	1/34 (2.9%)	1	1/33 (3%)	1
Bronchiolitis	2/34 (5.9%)	2	2/35 (5.7%)	2	1/34 (2.9%)	2	1/33 (3%)	2
Other (Not Including Serious) Adverse Events
	Loteprednol Etabonate and Tobramycin		Loteprednol Etabonate		Tobramycin		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/34 (5.9%)		2/35 (5.7%)		2/34 (5.9%)		2/33 (6.1%)
Respiratory, thoracic and mediastinal disorders
Cough	2/34 (5.9%)	2	2/35 (5.7%)	2	2/34 (5.9%)	2	2/33 (6.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.