Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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)

Condition or disease Intervention/treatment Phase
Chalazion Hordeolum Drug: loteprednol etabonate/tobramycin opthalmic suspension Drug: vehicle Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Treatment Emergent Adverse Events [ Time Frame: day 1, day 8, day 15 ]
    Study eye - Safety Population, At all visits 1,2,3


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420628


Locations
Layout table for location information
United States, Pennsylvania
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, United States, 16501
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Layout table for investigator information
Study Director: Timothy L Comstock, OD Bausch & Lomb Incorporated
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00420628    
Other Study ID Numbers: 459
First Posted: January 11, 2007    Key Record Dates
Results First Posted: September 22, 2010
Last Update Posted: October 7, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Hordeolum
Chalazion
Cysts
Neoplasms
Eyelid Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
 Bacterial Infections and Mycoses
Infections
Eye Infections
Loteprednol Etabonate
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Allergic Agents