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A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

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ClinicalTrials.gov Identifier: NCT01449526
Recruitment Status : Completed
First Posted : October 10, 2011
Results First Posted : February 18, 2015
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator)
Condition Myopia
Interventions Device: B&L Investigational Contact Lens
Device: B&L PureVision Contact Lens
Enrollment 166
Recruitment Details This was a three month study enrolling 166 participants from 12 investigative sites in the United States. First participant was enroled on 08/08/2011, and last participant exited the study on 12/08/2011.
Pre-assignment Details 166 participants were enrolled in the study with 158 participants completing the study. A minimum of 68 participants were to be of Japanese descent (both maternal and paternal grandparents born in Japan) for submission to the Japanese Regulatory Agency.
Arm/Group Title B&L Investigational Contact Lens B&L PureVision Contact Lens
Hide Arm/Group Description

The Bausch + Lomb investigational silicone hydrogel contact lens

B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

The Bausch + Lomb PureVision silicone hydrogel contact lens

B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

Period Title: Overall Study
Started 83 83
Completed 81 77
Not Completed 2 6
Reason Not Completed
Lost to Follow-up             1             2
Withdrawal by Subject             1             1
Symptoms/complaints             0             1
Lack of Motivation             0             1
Cannot maintain visits             0             1
Arm/Group Title B&L Investigational Contact Lens B&L PureVision Contact Lens Total
Hide Arm/Group Description

The Bausch + Lomb investigational silicone hydrogel contact lens

B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

The Bausch + Lomb PureVision silicone hydrogel contact lens

B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

Total of all reporting groups
Overall Number of Baseline Participants 83 83 166
Hide Baseline Analysis Population Description
All Eligible, Dispensed Subjects
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 83 participants 83 participants 166 participants
29.0
(19 to 40)
29.0
(18 to 40)
29.0
(18 to 40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 83 participants 166 participants
Female
58
  69.9%
50
  60.2%
108
  65.1%
Male
25
  30.1%
33
  39.8%
58
  34.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 83 participants 166 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
53
  63.9%
55
  66.3%
108
  65.1%
Native Hawaiian or Other Pacific Islander
1
   1.2%
2
   2.4%
3
   1.8%
Black or African American
2
   2.4%
2
   2.4%
4
   2.4%
White
25
  30.1%
24
  28.9%
49
  29.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   2.4%
0
   0.0%
2
   1.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 83 participants 83 participants 166 participants
83 83 166
1.Primary Outcome
Title Visual Acuity (VA)
Hide Description Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.
Time Frame 4 visits over 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Eligible, Dispensed Eyes
Arm/Group Title B&L Investigational Contact Lens B&L PureVision Contact Lens
Hide Arm/Group Description:

The Bausch + Lomb investigational silicone hydrogel contact lens

B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

The Bausch + Lomb PureVision silicone hydrogel contact lens

B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

Overall Number of Participants Analyzed 83 83
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
166 166
Least Squares Mean (Standard Deviation)
Unit of Measure: LogMAR
-0.033  (0.054) -0.038  (0.054)
2.Secondary Outcome
Title Slit Lamp > Grade 2
Hide Description Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of dispensed eyes with non-missing scores in each treatment group.
Arm/Group Title B&L Investigational Contact Lens B&L PureVision Contact Lens
Hide Arm/Group Description:

The Bausch + Lomb investigational silicone hydrogel contact lens

B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

The Bausch + Lomb PureVision silicone hydrogel contact lens

B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

Overall Number of Participants Analyzed 82 82
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
164 164
Measure Type: Number
Unit of Measure: eyes (2 per participant)
2 5
Time Frame 3 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title B&L Investigational Contact Lens B&L PureVision Contact Lens
Hide Arm/Group Description

The Bausch + Lomb investigational silicone hydrogel contact lens

B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

The Bausch + Lomb PureVision silicone hydrogel contact lens

B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

All-Cause Mortality
B&L Investigational Contact Lens B&L PureVision Contact Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
B&L Investigational Contact Lens B&L PureVision Contact Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   0/83 (0.00%)   0/83 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
B&L Investigational Contact Lens B&L PureVision Contact Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   0/83 (0.00%)   0/83 (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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Steffen, OD, MS
Organization: Bausch & Lomb Incorporated
Phone: 585-338-6399
EMail: robert.steffen@bausch.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01449526     History of Changes
Other Study ID Numbers: 661
First Submitted: October 6, 2011
First Posted: October 10, 2011
Results First Submitted: March 28, 2014
Results First Posted: February 18, 2015
Last Update Posted: February 18, 2015