Back to resultsA Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Novel Bausch & Lomb daily disposable contact lenses
Bausch & Lomb SofLens daily disposable contact lenses.
Johnson and Johnson 1-Day Acuvue Moist contact lenses
Sponsored by
About this trial
This is an interventional supportive care trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Subjects with VA correctable to 0.3 logMAR (driving vision) or better in each eye.
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be myopic and require lens correction in both eyes.
Exclusion Criteria:
- Subjects with any systemic disease affecting ocular health.
- Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Subjects wearing monovision, multifocal or toric contact lenses.
- Subjects with grade 2 or greater slit lamp findings.
Sites / Locations
- Dr. James Ferrari
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Novel Bausch & Lomb Contact Lens
SofLens
Acuvue
Arm Description
Novel Bausch & Lomb daily disposable contact lenses
Bausch & Lomb SofLens daily disposable contact lenses
Johnson and Johnson 1-Day Acuvue Moist contact lenses
Outcomes
Primary Outcome Measures
Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey
The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater.
Secondary Outcome Measures
Full Information
NCT ID
NCT00784641
First Posted
October 31, 2008
Last Updated
September 11, 2020
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00784641
Brief Title
A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the clinical performance of a novel Bausch & Lomb daily disposable contact lens when compared to the currently marketed Bausch & Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers on a daily disposable basis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
567 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Novel Bausch & Lomb Contact Lens
Arm Type
Experimental
Arm Description
Novel Bausch & Lomb daily disposable contact lenses
Arm Title
SofLens
Arm Type
Active Comparator
Arm Description
Bausch & Lomb SofLens daily disposable contact lenses
Arm Title
Acuvue
Arm Type
Active Comparator
Arm Description
Johnson and Johnson 1-Day Acuvue Moist contact lenses
Intervention Type
Device
Intervention Name(s)
Novel Bausch & Lomb daily disposable contact lenses
Intervention Description
Lenses to be worn and replaced daily for 2 weeks.
Intervention Type
Device
Intervention Name(s)
Bausch & Lomb SofLens daily disposable contact lenses.
Intervention Description
Lenses to be worn and replaced daily for 2 weeks.
Intervention Type
Device
Intervention Name(s)
Johnson and Johnson 1-Day Acuvue Moist contact lenses
Intervention Description
Lenses to be worn and replaced daily for 2 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey
Description
The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater.
Time Frame
At dispensing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with VA correctable to 0.3 logMAR (driving vision) or better in each eye.
Subjects must have clear central corneas and be free of any anterior segment disorders.
Subjects must be myopic and require lens correction in both eyes.
Exclusion Criteria:
Subjects with any systemic disease affecting ocular health.
Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
Subjects wearing monovision, multifocal or toric contact lenses.
Subjects with grade 2 or greater slit lamp findings.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bev Barna
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Dr. James Ferrari
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use
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