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Pediatric Zylet Safety and Efficacy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00420628
Recruitment Status : Completed
First Posted : January 11, 2007
Results First Posted : September 22, 2010
Last Update Posted : October 7, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Tracking Information
First Submitted Date  ICMJE January 8, 2007
First Posted Date  ICMJE January 11, 2007
Results First Submitted Date  ICMJE March 19, 2010
Results First Posted Date  ICMJE September 22, 2010
Last Update Posted Date October 7, 2011
Study Start Date  ICMJE November 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2010)
Treatment Emergent Adverse Events [ Time Frame: day 1, day 8, day 15 ]
Study eye - Safety Population, At all visits 1,2,3
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2007)
Safety (review of adverse events)
Change History Complete list of historical versions of study NCT00420628 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2010)
  • Investigators Global Assessment of the Clinical Condition [ Time Frame: 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.
  • Assessment of Ocular Signs in the Study Eye - Visit 1 [ Time Frame: 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.
  • Assessment of Ocular Signs in the Study Eye - Visit 2 [ Time Frame: 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.
  • Assessment of Ocular Signs in the Study Eye - Visit 3 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2007)
Efficacy (number of study eyes with clinical improvement)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Zylet Safety and Efficacy Study
Official Title  ICMJE 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
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chalazion
  • Hordeolum
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Loteprednol/Tobramycin
    0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension
    Intervention: Drug: loteprednol etabonate/tobramycin opthalmic suspension
  • Placebo Comparator: Vehicle
    Vehicle
    Intervention: Drug: vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2007)
108
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00420628
Other Study ID Numbers  ICMJE 459
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch & Lomb Incorporated
Study Sponsor  ICMJE Bausch & Lomb Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Timothy L Comstock, OD Bausch & Lomb Incorporated
PRS Account Bausch & Lomb Incorporated
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP