Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers
1 other identifier
interventional
272
1 country
1
Brief Summary
This study is being conducted to evaluate Bausch \& Lomb PureVision Multi-Focal contact lenses compared to the Bausch \& Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear 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 Sep 2009
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 25, 2009
CompletedFirst Posted
Study publicly available on registry
September 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
March 14, 2011
CompletedMarch 24, 2015
March 1, 2015
2 months
September 25, 2009
February 17, 2011
March 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.
Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.
2 weeks
Secondary Outcomes (1)
Subjective Ratings of Eye Strain
2 week visit
Study Arms (2)
PureVision Multi-Focal contact lenses
EXPERIMENTALSofLens59 contact lens
ACTIVE COMPARATORInterventions
Contact lenses to be worn on a daily wear basis for 2 weeks.
Contact lenses to be worn on a daily wear basis for 2 weeks.
Eligibility Criteria
You may qualify if:
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
- Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.
You may not qualify if:
- Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
- Subjects with any systemic disease affecting ocular health
- Subjects with an active ocular disease or using any ocular medication.
- Subjects who have had any corneal surgery (eg, refractive surgery).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- William Reindel, OD, MS
- Organization
- Bausch & Lomb Incorporated
Study Officials
- STUDY DIRECTOR
Beverly J 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
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2009
First Posted
September 28, 2009
Study Start
September 1, 2009
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
March 24, 2015
Results First Posted
March 14, 2011
Record last verified: 2015-03