One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 15, 2009
CompletedResults Posted
Study results publicly available
March 2, 2015
CompletedMarch 2, 2015
February 1, 2015
1 month
May 14, 2009
February 13, 2015
February 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Insertion, 4 hours & End of Day
Study Arms (2)
SofLens Daily Disposable
EXPERIMENTALSofLens Daily Disposable Lenses
Marketed 1 Day Contact Lens
ACTIVE COMPARATORMarketed 1 Day Contact Lens
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Participating in a conflicting study.
- Considered by the Investigator to not be a suitable candidate for participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb Research Clinic
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Steffen, OD, MS
- Organization
- Bausch & Lomb Incorporated
Study Officials
- STUDY DIRECTOR
Robert Steffen, OD, MS
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 15, 2009
Study Start
October 1, 2008
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
March 2, 2015
Results First Posted
March 2, 2015
Record last verified: 2015-02