A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use
1 other identifier
interventional
567
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 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
First Submitted
Initial submission to the registry
October 31, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedFirst Posted
Study publicly available on registry
November 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
October 6, 2020
CompletedOctober 6, 2020
September 1, 2020
1 month
October 31, 2008
August 21, 2020
September 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
At dispensing
Study Arms (3)
Novel Bausch & Lomb Contact Lens
EXPERIMENTALNovel Bausch \& Lomb daily disposable contact lenses
SofLens
ACTIVE COMPARATORBausch \& Lomb SofLens daily disposable contact lenses
Acuvue
ACTIVE COMPARATORJohnson and Johnson 1-Day Acuvue Moist contact lenses
Interventions
Lenses to be worn and replaced daily for 2 weeks.
Lenses to be worn and replaced daily for 2 weeks.
Lenses to be worn and replaced daily for 2 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. James Ferrari
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Bev Barna
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2008
First Posted
November 4, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2008
Study Completion
January 1, 2009
Last Updated
October 6, 2020
Results First Posted
October 6, 2020
Record last verified: 2020-09