Pediatric Zylet Safety and Efficacy Study - Full Text View

Sponsor:	Bausch & Lomb, Inc.
Information provided by (Responsible Party):	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00420628

Purpose

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	Intervention	Phase
Chalazion Hordeolum	Drug: loteprednol etabonate/tobramycin opthalmic suspension Drug: vehicle	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Tobramycin Tobramycin sulfate Loteprednol etabonate Loteprednol

U.S. FDA Resources

Further study details as provided by Bausch & Lomb, Inc.:

Primary Outcome Measures:

Treatment Emergent Adverse Events [ Time Frame: day 1, day 8, day 15 ] [ Designated as safety issue: No ]
Study eye - Safety Population, At all visits 1,2,3

Secondary Outcome Measures:

Investigators Global Assessment of the Clinical Condition [ Time Frame: Visit 3, day 8 ] [ Designated as safety issue: No ]
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 [ Time Frame: Visit 1 (day 1) ] [ Designated as safety issue: No ]
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 [ Time Frame: Visit 2 (day 8) ] [ Designated as safety issue: No ]
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 [ Time Frame: Visit 3 (day 15) ] [ Designated as safety issue: No ]
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.

Enrollment:	108
Study Start Date:	November 2006
Study Completion Date:	June 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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.

Eligibility

Ages Eligible for Study:	up to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420628

Locations

United States, Pennsylvania
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, United States, 16501

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Study Director:

Timothy L Comstock, OD

Bausch & Lomb, Inc.

More Information

No publications provided

Responsible Party:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00420628 History of Changes
Other Study ID Numbers:	459
Study First Received:	January 8, 2007
Results First Received:	March 19, 2010
Last Updated:	September 30, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Chalazion
Hordeolum
Cysts
Neoplasms
Eyelid Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections

Infection
Tobramycin
Loteprednol etabonate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on February 09, 2012