A Study to Evaluate the Product Performance of the PureVision®2 High Definition (HD) Contact Lens
1 other identifier
interventional
63
1 country
1
Brief Summary
The objective of this study is to evaluate the product performance of PureVision2 HD contact lenses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2011
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
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 11, 2011
CompletedFirst Posted
Study publicly available on registry
August 12, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
December 25, 2013
CompletedDecember 25, 2013
November 1, 2013
1 month
August 11, 2011
February 13, 2013
November 7, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Acuity
Visual acuity(VA) measured at the screening visit (all eligible participants) while wearing spectacles and the VA measured at the end of study (Visit 3) 1-Week wearing PureVision2 HD lenses. VA wearing spectacles vs. VA wearing PureVision2 HD Lenses, lower the number the better the VA.
Screening visit (Visit 1) and one week follow-up(Visit 3)
Secondary Outcomes (1)
Preference for Test Lens
During the movie (Visit 2)
Study Arms (2)
Spectacles
ACTIVE COMPARATORThe subject's habitual spectacles (updated or confirmed as correct within the last 2 years)
PureVision2 HD contact lenses
EXPERIMENTALCurrently marketed Bausch + Lomb PureVision2 HD contact lenses
Interventions
Lenses to be worn through 1/2 of an HD movie. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.
Eligibility Criteria
You may qualify if:
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings
- Subjects must be myopic or hyperopic and require lens correction in each eye
- Subjects must own a pair of spectacles and the spectacle prescription must have been updated or confirmed as correct within the last 2 years.
You may not qualify if:
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- Allergic to any component in the Biotrue multi-purpose solution
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bausch & Lomb, Inc.
Rochester, New York, 14609, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. William Reindel
- Organization
- Bausch & Lomb Incorporated
Study Officials
- STUDY DIRECTOR
Bev Barna, CCRA
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
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2011
First Posted
August 12, 2011
Study Start
July 1, 2011
Primary Completion
August 1, 2011
Study Completion
September 1, 2011
Last Updated
December 25, 2013
Results First Posted
December 25, 2013
Record last verified: 2013-11