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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chalazion
Hordeolum
Interventions Drug: loteprednol etabonate/tobramycin opthalmic suspension
Drug: vehicle
Enrollment 108
Recruitment Details 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 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.
Arm/Group Title Loteprednol/Tobramycin Vehicle
Hide Arm/Group Description 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days Vehicle used in the study drug administered into affected eye(s) for 14 days
Period Title: Overall Study
Started 72 36
Completed 63 32
Not Completed 9 4
Reason Not Completed
Withdrawn by parent or gaurdian             5             2
Lost to Follow-up             3             2
Adverse Event             1             0
Arm/Group Title Loteprednol/Tobramycin Vehicle Total
Hide Arm/Group Description 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days Vehicle used in the study drug administered into affected eye(s) for 14 days Total of all reporting groups
Overall Number of Baseline Participants 72 36 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Age 0-6 years Number Analyzed 72 participants 36 participants 108 participants
72 36 108
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 36 participants 108 participants
Female
37
  51.4%
23
  63.9%
60
  55.6%
Male
35
  48.6%
13
  36.1%
48
  44.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 72 participants 36 participants 108 participants
Asian 3 1 4
Black or African American 10 7 17
White 52 25 77
Other 7 3 10
1.Primary Outcome
Title Treatment Emergent Adverse Events
Hide Description Study eye - Safety Population, At all visits 1,2,3
Time Frame day 1, day 8, day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, Study eye
Arm/Group Title Loteprednol/Tobramycin Vehicle
Hide Arm/Group Description:
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
Vehicle used in the study drug administered into affected eye(s) for 14 days
Overall Number of Participants Analyzed 72 36
Measure Type: Number
Unit of Measure: participants
Conjunctivitis 2 0
Meibomianitis 1 1
Eyelid edema 0 1
2.Secondary Outcome
Title Investigators Global Assessment of the Clinical Condition
Hide Description 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.
Time Frame Visit 3, day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Sample, subjects with non-missing data. Day 15 (Visit 3)
Arm/Group Title Loteprednol/Tobramycin Vehicle
Hide Arm/Group Description:
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
Vehicle used in the study drug administered into affected eye(s) for 14 days
Overall Number of Participants Analyzed 63 32
Measure Type: Number
Unit of Measure: Participants
Improved 36 17
Unchanged 25 13
Worse 2 2
3.Secondary Outcome
Title Assessment of Ocular Signs in the Study Eye - Visit 1
Hide Description Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Time Frame Visit 1 (day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample, non-missing data
Arm/Group Title Loteprednol/Tobramycin Vehicle
Hide Arm/Group Description:
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
Vehicle used in the study drug administered into affected eye(s) for 14 days
Overall Number of Participants Analyzed 66 34
Mean (Standard Deviation)
Unit of Measure: Units on a scale 0-4
Lid Edema 1.97  (0.84) 2.06  (0.95)
Lid Erythema 1.98  (1.10) 1.82  (1.22)
Palpebral Conjunctival Injection 1.85  (1.13) 1.79  (0.98)
Meibomian Plugging 1.44  (1.04) 1.59  (1.26)
4.Secondary Outcome
Title Assessment of Ocular Signs in the Study Eye - Visit 2
Hide Description Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Time Frame Visit 2 (day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population - Study eye
Arm/Group Title Loteprednol/Tobramycin Vehicle
Hide Arm/Group Description:
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
Vehicle used in the study drug administered into affected eye(s) for 14 days
Overall Number of Participants Analyzed 66 32
Mean (Standard Deviation)
Unit of Measure: Units on a scale 0-4
Lid Edema 1.47  (0.92) 1.38  (0.94)
Lid Erythema 1.41  (1.01) 1.47  (1.08)
Palpebral Conjunctival Injection 1.41  (1.01) 1.16  (0.92)
Meibomian Plugging 1.06  (1.02) 1.00  (1.11)
5.Secondary Outcome
Title Assessment of Ocular Signs in the Study Eye - Visit 3
Hide Description Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Time Frame Visit 3 (day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy sample - Study eye
Arm/Group Title Loteprednol/Tobramycin Vehicle
Hide Arm/Group Description:
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
Vehicle used in the study drug administered into affected eye(s) for 14 days
Overall Number of Participants Analyzed 63 32
Mean (Standard Deviation)
Unit of Measure: Units on a scale 0-4
Lid Edema 1.03  (0.90) 1.41  (1.10)
Lid Erythema 1.00  (0.88) 1.50  (1.14)
Palpebral Conjunctival Injection 1.11  (0.95) 1.09  (1.09)
Meibomian Plugging 0.86  (1.12) 1.16  (1.22)
Time Frame 14 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Loteprednol/Tobramycin Vehicle
Hide Arm/Group Description 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days Vehicle used in the study drug administered into affected eye(s) for 14 days
All-Cause Mortality
Loteprednol/Tobramycin Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Loteprednol/Tobramycin Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/72 (1.39%)      0/36 (0.00%)    
Vascular disorders     
bilateral subdural hematoma  1  1/72 (1.39%)  1 0/36 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Loteprednol/Tobramycin Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/72 (0.00%)      0/36 (0.00%)    
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 results of the study may be published or presented by the investigator(s) after the review by, and in consultation and agreement with Bausch & Lomb, and such that confidential or proprietary information is not disclosed.

Prior to publication or presentation, a copy of the final text should be forwarded by the investigator(s) to Bausch & Lomb or its designee, for comment.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Timothy Comstock OD
Organization: Bausch & Lomb
Phone: (585) 338-6631
EMail: tcomstock@bausch.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00420628    
Other Study ID Numbers: 459
First Submitted: January 8, 2007
First Posted: January 11, 2007
Results First Submitted: March 19, 2010
Results First Posted: September 22, 2010
Last Update Posted: October 7, 2011