Back to resultsOne-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SofLens Daily Disposable
Marketed 1 Day Contact Lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Have no active ocular disease or allergic conjunctivitis.
- Not be using any topical ocular medications.
Exclusion Criteria:
- Participating in a conflicting study.
- Considered by the Investigator to not be a suitable candidate for participation.
Sites / Locations
- Bausch & Lomb Research Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SofLens Daily Disposable
Marketed 1 Day Contact Lens
Arm Description
SofLens Daily Disposable Lenses
Marketed 1 Day Contact Lens
Outcomes
Primary Outcome Measures
Clinical Performance
Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.
Secondary Outcome Measures
Full Information
NCT ID
NCT00902850
First Posted
May 14, 2009
Last Updated
February 13, 2015
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00902850
Brief Title
One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens
Official Title
One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to 1-Day Acuvue TruEye Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (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
The objective of this one-day study will be to evaluate the clinical performance of SofLens Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SofLens Daily Disposable
Arm Type
Experimental
Arm Description
SofLens Daily Disposable Lenses
Arm Title
Marketed 1 Day Contact Lens
Arm Type
Active Comparator
Arm Description
Marketed 1 Day Contact Lens
Intervention Type
Device
Intervention Name(s)
SofLens Daily Disposable
Intervention Description
Lenses to be worn for 8-16 hours
Intervention Type
Device
Intervention Name(s)
Marketed 1 Day Contact Lens
Intervention Description
Lenses to be worn for 8-16 hours
Primary Outcome Measure Information:
Title
Clinical Performance
Description
Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.
Time Frame
Insertion, 4 hours & End of Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
Have no active ocular disease or allergic conjunctivitis.
Not be using any topical ocular medications.
Exclusion Criteria:
Participating in a conflicting study.
Considered by the Investigator to not be a suitable candidate for participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Steffen, OD, MS
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Research Clinic
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
12. IPD Sharing Statement
Learn more about this trial
One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens
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