Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01240122
First received: November 8, 2010
Last updated: June 7, 2012
Last verified: June 2012
Results First Received: February 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Condition: Corneal Staining
Interventions: Device: Biotrue MPS
Device: Investigational MPS

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Biotrue/Investigational MPS Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.

Participant Flow:   Overall Study
    Biotrue/Investigational MPS  
STARTED     29  
COMPLETED     29  
NOT COMPLETED     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.
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Reporting Groups
  Description
Biotrue/Investigational MPS Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.

Baseline Measures
    Biotrue/Investigational MPS  
Number of Participants  
[units: participants]
  29  
Age, Customized  
[units: participants]
 
<18 years     0  
18 years of age or older     29  
Gender, Customized [1]
[units: participants]
 
Male     0  
Female     0  
Unknown     29  
[1] Gender was not an analysis endpoint for this study.



  Outcome Measures
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1.  Primary:   Corneal Staining by Wear Time   [ Time Frame: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4 ]

2.  Secondary:   Overall Ocular Comfort   [ Time Frame: Day 4 ]

3.  Secondary:   Subjective Solution Preference   [ Time Frame: Day 4 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Manager, Clinical Research
Organization: Abbott Medical Optics
phone: 714.247.8723
e-mail: eugenia.kao@amo.abbott.com


No publications provided


Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01240122     History of Changes
Other Study ID Numbers: COBR-109-9608
Study First Received: November 8, 2010
Results First Received: February 15, 2012
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration