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

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ClinicalTrials.gov Identifier: NCT01268501
Recruitment Status : Completed
First Posted : December 31, 2010
Results First Posted : February 9, 2012
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Presbyopia
Intervention Device: Lotrafilcon B multifocal contact lens
Enrollment 103
Recruitment Details A total of 103 participants were recruited at 25 US sites from December 8, 2010, to January 31, 2011.
Pre-assignment Details 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.
Arm/Group Title Lotrafilcon B Multifocal
Hide Arm/Group Description Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
Period Title: Overall Study
Started 96
Completed 87
Not Completed 9
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             3
Unacceptable Subjective Vision             3
Handling Difficulties             2
Arm/Group Title Lotrafilcon B Multifocal
Hide Arm/Group Description Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
Overall Number of Baseline Participants 96
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants
44.9  (2.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants
Female
72
  75.0%
Male
24
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 96 participants
96
1.Primary Outcome
Title Overall Convenience With Contact Lenses
Hide Description Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, "very satisfied" or "satisfied."
Time Frame 3 weeks of wear
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review.
Arm/Group Title Lotrafilcon B Multifocal
Hide Arm/Group Description:
Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
Overall Number of Participants Analyzed 85
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
82.4
(72.6 to 89.8)
Time Frame Adverse event data were collected for the duration of the trial: 76 days.
Adverse Event Reporting Description This reporting group includes all enrolled and exposed participants.
 
Arm/Group Title Lotrafilcon B Multifocal
Hide Arm/Group Description Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
All-Cause Mortality
Lotrafilcon B Multifocal
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lotrafilcon B Multifocal
Affected / at Risk (%)
Total   0/101 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lotrafilcon B Multifocal
Affected / at Risk (%)
Total   0/101 (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.
For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Alcon Clinical
Organization: Alcon Research, Ltd.
Phone: 1-800-241-7629
Layout table for additonal information
Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01268501     History of Changes
Other Study ID Numbers: P-319-C-019
First Submitted: December 29, 2010
First Posted: December 31, 2010
Results First Submitted: January 13, 2012
Results First Posted: February 9, 2012
Last Update Posted: June 29, 2012