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Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products

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: NCT00909792
Recruitment Status : Completed
First Posted : May 28, 2009
Results First Posted : October 29, 2010
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Presbyopia
Interventions Device: Lotrafilcon B
Device: Senofilcon A
Enrollment 259
Recruitment Details  
Pre-assignment Details One participant was enrolled but not dispensed due to failing inclusion/exclusion criteria. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
Arm/Group Title Lotrafilcon B / Senofilcon A Senofilcon A / Lotrafilcon B
Hide Arm/Group Description Lotrafilcon B multifocal contact lenses worn first, with Senofilcon A multifocal contact lenses worn second. Both products worn in a daily wear basis. Senofilcon A multifocal contact lenses worn first, with Lotrafilcon B multifocal contact lenses worn second. Both products worn in a daily wear basis.
Period Title: Period 1
Started 130 128
Completed 130 127
Not Completed 0 1
Reason Not Completed
Did not meet inclusion criteria             0             1
Period Title: Period 2
Started 129 [1] 125 [2]
Completed 128 124
Not Completed 1 1
Reason Not Completed
Biomicroscopy             1             0
Lost to Follow-up             0             1
[1]
One participant discontinued between Period 1 and Period 2 due to lack of efficacy.
[2]
Two discontinuations between P1 & P2: 1 for fail inc/exc criteria; 1 for lack of efficacy.
Arm/Group Title Overall
Hide Arm/Group Description This reporting group includes all enrolled and dispensed subjects.
Overall Number of Baseline Participants 258
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 258 participants
45.5  (4.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 258 participants
Female
222
  86.0%
Male
36
  14.0%
1.Primary Outcome
Title Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
Hide Description Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.
Time Frame After 1 week of wear
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol. Analysis excluded major protocol deviations as determined by masked review.
Arm/Group Title Lotrafilcon B Multifocal Contact Lens Senofilcon A Multifocal Contact Lens
Hide Arm/Group Description:
Silicone hydrogel, soft, multifocal contact lens
Silicone hydrogel, soft, multifocal contact lens
Overall Number of Participants Analyzed 237 234
Mean (Standard Deviation)
Unit of Measure: logMAR
-0.01  (0.06) 0.01  (0.07)
Time Frame 46 days, duration of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lotrafilcon B Senofilcon A
Hide Arm/Group Description Silicone hydrogel, soft, multifocal contact lens Silicone hydrogel, soft, multifocal contact lens
All-Cause Mortality
Lotrafilcon B Senofilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Lotrafilcon B Senofilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/256 (0.00%)   0/258 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lotrafilcon B Senofilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/256 (0.00%)   0/258 (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 pre-clinical and/or clinical data or impressions from this trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
Organization: CIBA VISION
Phone: 1-800-241-7629
EMail: priya.janakiraman@cibavision.com
Layout table for additonal information
Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT00909792    
Other Study ID Numbers: P-319-C-013
First Submitted: May 27, 2009
First Posted: May 28, 2009
Results First Submitted: September 16, 2010
Results First Posted: October 29, 2010
Last Update Posted: June 29, 2012