Pediatric Zylet Safety and Efficacy Study
Primary Purpose
Chalazion, Hordeolum
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
loteprednol etabonate/tobramycin opthalmic suspension
vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Chalazion
Eligibility Criteria
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
Sites / Locations
- Pediatric Ophthalmology of Erie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Loteprednol/Tobramycin
Vehicle
Arm Description
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension
Vehicle
Outcomes
Primary Outcome Measures
Treatment Emergent Adverse Events
Study eye - Safety Population, At all visits 1,2,3
Secondary Outcome Measures
Investigators Global Assessment of the Clinical Condition
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.
Assessment of Ocular Signs in the Study Eye - Visit 1
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Assessment of Ocular Signs in the Study Eye - Visit 2
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Assessment of Ocular Signs in the Study Eye - Visit 3
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Full Information
NCT ID
NCT00420628
First Posted
January 8, 2007
Last Updated
September 30, 2011
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00420628
Brief Title
Pediatric Zylet Safety and Efficacy Study
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 Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chalazion, Hordeolum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loteprednol/Tobramycin
Arm Type
Experimental
Arm Description
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
loteprednol etabonate/tobramycin opthalmic suspension
Other Intervention Name(s)
Zylet
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
vehicle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Emergent Adverse Events
Description
Study eye - Safety Population, At all visits 1,2,3
Time Frame
day 1, day 8, day 15
Secondary Outcome Measure Information:
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
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)
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)
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)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy L Comstock, OD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Pediatric Ophthalmology of Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16501
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pediatric Zylet Safety and Efficacy Study
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