Comparative Performance of PureVision, Acuvue Oasys and O2Optix
Product Performance of Bausch & Lomb PureVision® Contact Lens When Compared to Johnson & Johnson Acuvue Oasys Contact Lens and the Ciba Vision O2Optix Contact Lens Worn Daily.
1 other identifier
interventional
510
1 country
1
Brief Summary
The objective of this study is to evaluate the performance of the PureVision Contact Lens compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn 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 phase_4
Started Feb 2008
Shorter than P25 for phase_4
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
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 20, 2008
CompletedFirst Posted
Study publicly available on registry
March 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
March 31, 2011
CompletedDecember 12, 2011
December 1, 2011
2 months
February 20, 2008
February 3, 2011
December 7, 2011
Conditions
Outcome Measures
Primary Outcomes (3)
Any Slit Lamp Finding > Grade 2
All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal \& bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured.
Over all follow-up visits for the 1 month study period
Subjective Responses to Comfort-related Symptoms/Complaints
Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.
Over all follow-up visits for 1 month study period
Uncorrected Distance High Contrast Visual Acuity
logMAR high contrast visual acuity (VA) over all visits.
Over all visits for the 1 month study period
Study Arms (3)
PureVision
EXPERIMENTALPureVision Contact Lens
Acuvue Oasys
ACTIVE COMPARATORAcuvue Oasys Contact Lens
O2Optix
ACTIVE COMPARATORO2Optix Contact Lens
Interventions
Eligibility Criteria
You may qualify if:
- Subject is myopic
- VA correctable to 0.3 LogMAR or better (driving vision)
- Clear central cornea
- Subject uses a lens care system on a regular basis
You may not qualify if:
- Systemic disease affecting ocular health
- Using systemic or topical medications
- Wear monovision, multifocal or toric contact lenses
- Any grade 2 or greater slit lamp findings
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anderson & Associates
Tampa, Florida, 33612, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Cairns
- Organization
- Bausch & Lomb Incorporated
Study Officials
- STUDY DIRECTOR
Gerard Cairns, MCOptom, PhD
Bausch & Lomb Incorporated
- PRINCIPAL INVESTIGATOR
Bruce Anderson, OD
Anderson & Associates
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2008
First Posted
March 21, 2008
Study Start
February 1, 2008
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
December 12, 2011
Results First Posted
March 31, 2011
Record last verified: 2011-12