Pediatric Zylet Safety and Efficacy Study

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00420628
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)

Condition or Disease	Intervention/Treatment	Phase
Chalazion; Hordeolum	Drug: loteprednol etabonate/tobramycin opthalmic suspension; Drug: vehicle	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Safety and Efficacy Study of Zylet® (Loteprednol Etabonate 0.5% and Tobramycin 0.3% Ophthalmic Suspension) Compared to Vehicle in the Management of Lid Inflammation (Chalazion/Hordeolum) in Pediatric Subjects
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Loteprednol/Tobramycin 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension	Drug: loteprednol etabonate/tobramycin opthalmic suspension; Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.; Other Names: Zylet
Placebo Comparator: Vehicle Vehicle	Drug: vehicle; topical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.

Outcome Measures

Primary Outcome Measures

1. Treatment Emergent Adverse Events [day 1, day 8, day 15]

   Study eye - Safety Population, At all visits 1,2,3

Secondary Outcome Measures

1. Investigators Global Assessment of the Clinical Condition [Visit 3, day 8]

   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.

2. Assessment of Ocular Signs in the Study Eye - Visit 1 [Visit 1 (day 1)]

   Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.

3. Assessment of Ocular Signs in the Study Eye - Visit 2 [Visit 2 (day 8)]

   Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.

4. Assessment of Ocular Signs in the Study Eye - Visit 3 [Visit 3 (day 15)]

   Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Child, 0 to 6 years of age, any sex and race

• Subject must have a clinical diagnosis of lid inflammation (e.g. Chalazion/Hordeolum) in at least one eye. If both eyes are diagnosed with lid inflammation, both eyes will be treated

• In good health (no current or past relevant medical history), based on the judgment of the investigator

• Parent/guardian is able and willing to follow instructions and provide informed consent

Exclusion Criteria:

• Known hypersensitivity to corticosteroids, loteprednol etabonate, or any component of the study medication

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

• Use of concurrent ocular therapy with non-steroidal anti-inflammatory agent (NSAID), mast cell stabilizer, antihistamine, or decongestant within 48 hours before and during the study

• Use of oral or topical ophthalmic corticosteroids (other than study medication) within 48 hours before and during the study

• Use of systemic antibiotics within 72 hours before and during the 14 day study medication treatment duration

• Use of topical ophthalmic antibiotics (other than the study medication) within 72 hours before and during the study

• History of ocular surgery, including laser procedures, within the past six months

• Anticipation that surgical intervention for lid inflammation will be required prior to completion of the study

• Subjects with suspected vernal conjunctivitis, glaucoma of any kind, viral or bacterial conjunctivitis, preseptal cellulitis requiring systemic antibiotics, dacryocystitis, uveitis, or any other disease conditions that could interfere with the safety and efficacy evaluations of the study medication

• History of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study

• Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study

• Unlikely to comply with the protocol instructions for any reason

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

• Study Director: Timothy L Comstock, OD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00420628
• Other Study ID Numbers: 459
• First Posted: Jan 11, 2007
• Last Update Posted: Oct 7, 2011
• Last Verified: Sep 1, 2011

• Additional relevant MeSH terms: Hordeolum; Chalazion; Loteprednol Etabonate; Tobramycin

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Loteprednol/Tobramycin	Vehicle
Arm/Group Description	0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days	Vehicle used in the study drug administered into affected eye(s) for 14 days
Period Title: Overall Study
STARTED	72	36
COMPLETED	63	32
NOT COMPLETED	9	4

Baseline Characteristics

Arm/Group Title	Loteprednol/Tobramycin	Vehicle	Total
Arm/Group Description	0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days	Vehicle used in the study drug administered into affected eye(s) for 14 days	Total of all reporting groups
Overall Participants	72	36	108
Age, Customized (participants) [Number]
Age 0-6 years	72 100%	36 100%	108 100%
Sex: Female, Male (Count of Participants)
Female	37 51.4%	23 63.9%	60 55.6%
Male	35 48.6%	13 36.1%	48 44.4%
Race/Ethnicity, Customized (participants) [Number]
Asian	3 4.2%	1 2.8%	4 3.7%
Black or African American	10 13.9%	7 19.4%	17 15.7%
White	52 72.2%	25 69.4%	77 71.3%
Other	7 9.7%	3 8.3%	10 9.3%

Outcome Measures

1. Secondary Outcome

Title	Investigators Global Assessment of the Clinical Condition
Description	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.
Time Frame	Visit 3, day 8

Outcome Measure Data

Analysis Population Description

Efficacy Sample, subjects with non-missing data. Day 15 (Visit 3)

Arm/Group Title	Loteprednol/Tobramycin	Vehicle
Arm/Group Description	0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days	Vehicle used in the study drug administered into affected eye(s) for 14 days
Measure Participants	63	32
Improved	36 50%	17 47.2%
Unchanged	25 34.7%	13 36.1%
Worse	2 2.8%	2 5.6%

2. Primary Outcome

Title	Treatment Emergent Adverse Events
Description	Study eye - Safety Population, At all visits 1,2,3
Time Frame	day 1, day 8, day 15

Outcome Measure Data

Analysis Population Description

Safety population, Study eye

Arm/Group Title	Loteprednol/Tobramycin	Vehicle
Arm/Group Description	0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days	Vehicle used in the study drug administered into affected eye(s) for 14 days
Measure Participants	72	36
Conjunctivitis	2 2.8%	0 0%
Meibomianitis	1 1.4%	1 2.8%
Eyelid edema	0 0%	1 2.8%

3. Secondary Outcome

Title	Assessment of Ocular Signs in the Study Eye - Visit 1
Description	Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Time Frame	Visit 1 (day 1)

Outcome Measure Data

Analysis Population Description

Efficacy sample, non-missing data

Arm/Group Title	Loteprednol/Tobramycin	Vehicle
Arm/Group Description	0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days	Vehicle used in the study drug administered into affected eye(s) for 14 days
Measure Participants	66	34
Lid Edema	1.97 (0.84)	2.06 (0.95)
Lid Erythema	1.98 (1.10)	1.82 (1.22)
Palpebral Conjunctival Injection	1.85 (1.13)	1.79 (0.98)
Meibomian Plugging	1.44 (1.04)	1.59 (1.26)

4. Secondary Outcome

Title	Assessment of Ocular Signs in the Study Eye - Visit 2
Description	Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Time Frame	Visit 2 (day 8)

Outcome Measure Data

Analysis Population Description

Efficacy population - Study eye

Arm/Group Title	Loteprednol/Tobramycin	Vehicle
Arm/Group Description	0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days	Vehicle used in the study drug administered into affected eye(s) for 14 days
Measure Participants	66	32
Lid Edema	1.47 (0.92)	1.38 (0.94)
Lid Erythema	1.41 (1.01)	1.47 (1.08)
Palpebral Conjunctival Injection	1.41 (1.01)	1.16 (0.92)
Meibomian Plugging	1.06 (1.02)	1.00 (1.11)

5. Secondary Outcome

Title	Assessment of Ocular Signs in the Study Eye - Visit 3
Description	Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Time Frame	Visit 3 (day 15)

Outcome Measure Data

Analysis Population Description

Efficacy sample - Study eye

Arm/Group Title	Loteprednol/Tobramycin	Vehicle
Arm/Group Description	0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days	Vehicle used in the study drug administered into affected eye(s) for 14 days
Measure Participants	63	32
Lid Edema	1.03 (0.90)	1.41 (1.10)
Lid Erythema	1.00 (0.88)	1.50 (1.14)
Palpebral Conjunctival Injection	1.11 (0.95)	1.09 (1.09)
Meibomian Plugging	0.86 (1.12)	1.16 (1.22)

Adverse Events

Time Frame	14 days
Arm/Group Title	Loteprednol/Tobramycin		Vehicle
Arm/Group Description	0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days		Vehicle used in the study drug administered into affected eye(s) for 14 days
All Cause Mortality
	Loteprednol/Tobramycin		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Loteprednol/Tobramycin		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/72 (1.4%)		0/36 (0%)
Vascular disorders
bilateral subdural hematoma	1/72 (1.4%)	1	0/36 (0%)	0
Other (Not Including Serious) Adverse Events
	Loteprednol/Tobramycin		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/72 (0%)		0/36 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.