Pediatric Zylet Safety and Efficacy Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00420628
First received: January 8, 2007
Last updated: September 30, 2011
Last verified: September 2011

January 8, 2007
September 30, 2011
November 2006
January 2009   (final data collection date for primary outcome measure)
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
Safety (review of adverse events)
Complete list of historical versions of study NCT00420628 on ClinicalTrials.gov Archive Site
  • 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.
Efficacy (number of study eyes with clinical improvement)
Not Provided
Not Provided
 
Pediatric Zylet Safety and Efficacy Study
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

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)

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chalazion
  • Hordeolum
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
June 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
up to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00420628
459
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Timothy L Comstock, OD Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
September 2011

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