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A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

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ClinicalTrials.gov Identifier: NCT01873846
Recruitment Status : Completed
First Posted : June 10, 2013
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Myopia
Intervention Device: Silicone Hydrogel Contact Lens
Enrollment 400
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Silicone Hydrogel Contact Lens
Hide Arm/Group Description

Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.

Silicone Hydrogel Contact Lens

Period Title: Overall Study
Started 400
Eligble Participants Dispensed Lenses 396
Completed 388
Not Completed 12
Arm/Group Title Silicone Hydrogel Contact Lens
Hide Arm/Group Description

Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.

Silicone Hydrogel Contact Lens

Overall Number of Baseline Participants 396
Hide Baseline Analysis Population Description
Eligible participants dispensed lenses
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 396 participants
26.8  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants
Female
278
  70.2%
Male
118
  29.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants
American Indian or Alaska Native
0
   0.0%
Asian
44
  11.1%
Native Hawaiian or Other Pacific Islander
2
   0.5%
Black or African American
14
   3.5%
White
327
  82.6%
More than one race
0
   0.0%
Unknown or Not Reported
9
   2.3%
1.Primary Outcome
Title Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
Hide Description Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: "How would you say these contact lenses compare overall with the contact lenses you usually use?" Prefer study lenses Prefer usual lenses About the same as usual lenses
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
There were 380 eligible subjects with lenses dispensed.
Arm/Group Title Silicone Hydrogel Contact Lens
Hide Arm/Group Description:

Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.

Silicone Hydrogel Contact Lens

Overall Number of Participants Analyzed 380
Measure Type: Count of Participants
Unit of Measure: Participants
Prefer study lenses
195
  51.3%
Prefer usual lenses
93
  24.5%
About the same as usual lens
92
  24.2%
2.Primary Outcome
Title Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.
Hide Description Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses deliver exceptional clarity and comfort all day long." Prefer study lenses Prefer usual lenses About the same as usual lenses
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
There were 380 eligible subjects with lenses dispensed.
Arm/Group Title Silicone Hydrogel Contact Lens
Hide Arm/Group Description:

Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.

Silicone Hydrogel Contact Lens

Overall Number of Participants Analyzed 380
Measure Type: Count of Participants
Unit of Measure: Participants
Prefer study lenses
199
  52.4%
Prefer usual lenses
80
  21.1%
About the same as usual lens
101
  26.6%
3.Primary Outcome
Title Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.
Hide Description Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses help maintain healthy, white eyes." Prefer study lenses Prefer usual lenses About the same as usual lenses
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
There were 380 eligible subjects with lenses dispensed.
Arm/Group Title Silicone Hydrogel Contact Lens
Hide Arm/Group Description:

Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.

Silicone Hydrogel Contact Lens

Overall Number of Participants Analyzed 380
Measure Type: Count of Participants
Unit of Measure: Participants
Prefer study lenses
162
  42.6%
Prefer usual lenses
51
  13.4%
About the same as usual lens
167
  43.9%
4.Secondary Outcome
Title Lens Performance Assessment
Hide Description High Contrast Distance logMAR Lens VA Change From Baseline to Week 2.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
High contrast distance lens visual acuity (VA) was assessed at Screening/Dispensing on the Test (newly dispensed) lenses, and at the follow-up visit(s). The population included subjects with baseline and at least one post-baseline assessment.
Arm/Group Title Silicone Hydrogel Contact Lens
Hide Arm/Group Description:

Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.

Silicone Hydrogel Contact Lens

Overall Number of Participants Analyzed 382
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
764
Mean (Standard Deviation)
Unit of Measure: Log of Minimum Angle of Resolution VA
0.004  (0.067)
5.Secondary Outcome
Title Any Graded Slit Lamp Finding > 2
Hide Description Slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Corneal staining grades were computed as the maximum grade over grades taken within each of five different eye locations (central, inferior, nasal, superior, and temporal). Eyes with multiple visits are counted once for the highest grade.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Percentages are based on the number of dispensed eyes with non-missing scores.
Arm/Group Title Silicone Hydrogel Contact Lens
Hide Arm/Group Description:

Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.

Silicone Hydrogel Contact Lens

Overall Number of Participants Analyzed 396
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
792
Count of Units
Unit of Measure: Eyes
2
   0.3%
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Silicone Hydrogel Contact Lens
Hide Arm/Group Description

Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.

Silicone Hydrogel Contact Lens

All-Cause Mortality
Silicone Hydrogel Contact Lens
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Silicone Hydrogel Contact Lens
Affected / at Risk (%)
Total   0/396 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Silicone Hydrogel Contact Lens
Affected / at Risk (%)
Total   0/396 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Robert Steffen
Organization: Bausch Health Americas, Inc
EMail: Robert.Steffen@bausch.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01873846     History of Changes
Other Study ID Numbers: 817
First Submitted: May 28, 2013
First Posted: June 10, 2013
Results First Submitted: July 1, 2019
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019