Pediatric Zylet Safety and Efficacy Study - Full Text View

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	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 0.5% and tobramycin 0.3% opthalmic suspension Drug: vehicle	Phase IV

Drug Information available for: Loteprednol Loteprednol etabonate Tobramycin Tobramycin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/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

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

Primary Outcome Measures:

Safety (review of adverse events) [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy (number of study eyes with clinical improvement) [ Time Frame: at the final visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	108
Study Start Date:	November 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: loteprednol etabonate 0.5% and tobramycin 0.3% opthalmic suspension topical ophthalmic drug
2: Placebo Comparator	Drug: vehicle topical ophthalmic drug

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

Contacts

Contact: Timothy L Comstock

(585)338-6631

Locations

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

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Study Director:

Timothy L Comstock, OD

Bausch & Lomb, Inc.

More Information

Responsible Party:	Bausch & Lomb, Inc. ( Timothy L Comstock )
Study ID Numbers:	459
Study First Received:	January 8, 2007
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00420628
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Eye Infections, Bacterial
Chalazion
Tobramycin
Eye Diseases

Eye Infections
Cysts
Loteprednol etabonate
Hordeolum
Inflammation

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Neoplasms
Therapeutic Uses

Eyelid Diseases
Anti-Allergic Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009