Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01268501
First received: December 29, 2010
Last updated: June 26, 2012
Last verified: February 2012
Results First Received: January 13, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Presbyopia
Intervention: Device: Lotrafilcon B multifocal contact lens

  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
A total of 103 participants were recruited at 25 US sites from December 8, 2010, to January 31, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seven participants were enrolled in the study but not dispensed due to failing inclusion/exclusion criteria (1); withdrawing consent/disinterest (4); discomfort (1); and unacceptable subjective vision (1). These participants are included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Reporting Groups
  Description
Lotrafilcon B Multifocal Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis

Participant Flow:   Overall Study
    Lotrafilcon B Multifocal  
STARTED     96  
COMPLETED     87  
NOT COMPLETED     9  
Lost to Follow-up                 1  
Withdrawal by Subject                 3  
Unacceptable Subjective Vision                 3  
Handling Difficulties                 2  



  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
Lotrafilcon B Multifocal Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis

Baseline Measures
    Lotrafilcon B Multifocal  
Number of Participants  
[units: participants]
  96  
Age  
[units: years]
Mean ± Standard Deviation
  44.9  ± 2.7  
Gender  
[units: participants]
 
Female     72  
Male     24  
Region of Enrollment  
[units: participants]
 
United States     96  



  Outcome Measures

1.  Primary:   Overall Convenience With Contact Lenses   [ Time Frame: 3 weeks of wear ]


  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
No text entered.


  More Information
  Hide More Information

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: Director of Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 1-800-241-7629


No publications provided


Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01268501     History of Changes
Other Study ID Numbers: P-319-C-019
Study First Received: December 29, 2010
Results First Received: January 13, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board