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
Results First Received: March 19, 2010  
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
Conditions: Chalazion
Hordeolum
Interventions: Drug: loteprednol etabonate/tobramycin opthalmic suspension
Drug: vehicle

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
108 subjects aged 0-6 years with lid inflammation were recruited from 15 clinic locations in the US. First subject was enrolled on 11/07/2006, last subject visit was 1/5/2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
108 subjects were randomized to receive loteprednol/tobramycin or its vehicle in a 2:1 ratio. Subjects will receive warm compress lid treatment 2 times daily, before administration of study medication (as applicable) for the 14-day treatment duration.

Reporting Groups
  Description
Loteprednol/Tobramycin 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
Vehicle Vehicle used in the study drug administered into affected eye(s) for 14 days

Participant Flow:   Overall Study
    Loteprednol/Tobramycin     Vehicle  
STARTED     72     36  
COMPLETED     63     32  
NOT COMPLETED     9     4  
Withdrawn by parent or gaurdian                 5                 2  
Lost to Follow-up                 3                 2  
Adverse Event                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Loteprednol/Tobramycin 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
Vehicle Vehicle used in the study drug administered into affected eye(s) for 14 days
Total Total of all reporting groups

Baseline Measures
    Loteprednol/Tobramycin     Vehicle     Total  
Number of Participants  
[units: participants]
  72     36     108  
Age, Customized  
[units: participants]
     
Age 0-6 years     72     36     108  
Gender  
[units: participants]
     
Female     37     23     60  
Male     35     13     48  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     3     1     4  
Black or African American     10     7     17  
White     52     25     77  
Other     7     3     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment Emergent Adverse Events   [ Time Frame: day 1, day 8, day 15 ]

2.  Secondary:   Investigators Global Assessment of the Clinical Condition   [ Time Frame: Visit 3, day 8 ]

3.  Secondary:   Assessment of Ocular Signs in the Study Eye - Visit 1   [ Time Frame: Visit 1 (day 1) ]

4.  Secondary:   Assessment of Ocular Signs in the Study Eye - Visit 2   [ Time Frame: Visit 2 (day 8) ]

5.  Secondary:   Assessment of Ocular Signs in the Study Eye - Visit 3   [ Time Frame: Visit 3 (day 15) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Timothy Comstock OD
Organization: Bausch & Lomb
phone: (585) 338-6631
e-mail: tcomstock@bausch.com


No publications provided


Responsible Party: Bausch & Lomb Incorporated
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