Study of the Presence and Extent of Corneal Disturbance Associated With B+L Biotrue MPS Used With B+L PureVision Lenses

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Epstein, Arthur B., OD, FAAO
ClinicalTrials.gov Identifier:
NCT01268306
First received: December 28, 2010
Last updated: August 18, 2016
Last verified: August 2016
Results First Received: August 18, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Keratitis
Intervention: Device: B+L Biotrue MPS and B+L PureVision

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects randomly recruited from contact lens wearing population in an optometric practice

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with spherical contact lens corrections who achieved acceptable acuity with test lenses were offered study participation.

Reporting Groups
  Description
Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses

Participant Flow:   Overall Study
    Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses  
STARTED     8  
COMPLETED     7  
NOT COMPLETED     1  
Lost to Follow-up                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses

Baseline Measures
    Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     0  
Gender  
[units: participants]
 
Female     5  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     8  



  Outcome Measures

1.  Primary:   Number of Participants Wiith Corneal Staining   [ Time Frame: 2-4 hours after contact lens insertion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
Pilot study with insignificant subject population for statistical analysis


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Arthur Epstein
Organization: Arthur B. Epstein, OD
phone: 424-226-2020
e-mail: artepstein@yahoo.com



Responsible Party: Epstein, Arthur B., OD, FAAO
ClinicalTrials.gov Identifier: NCT01268306     History of Changes
Other Study ID Numbers: CLC-01
Study First Received: December 28, 2010
Results First Received: August 18, 2012
Last Updated: August 18, 2016
Health Authority: United States: Food and Drug Administration