Back to resultsComparative Performance of PureVision, Acuvue Oasys and O2Optix
Primary Purpose
Myopia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PureVision Contact Lens
Acuvue Oasys Contact Lens
O2Optix Contact lens
Sponsored by
About this trial
This is an interventional supportive care trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Anderson & Associates
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
PureVision
Acuvue Oasys
O2Optix
Arm Description
PureVision Contact Lens
Acuvue Oasys Contact Lens
O2Optix Contact Lens
Outcomes
Primary Outcome Measures
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.
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.
Uncorrected Distance High Contrast Visual Acuity
logMAR high contrast visual acuity (VA) over all visits.
Secondary Outcome Measures
Full Information
NCT ID
NCT00640341
First Posted
February 20, 2008
Last Updated
December 7, 2011
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00640341
Brief Title
Comparative Performance of PureVision, Acuvue Oasys and O2Optix
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
510 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PureVision
Arm Type
Experimental
Arm Description
PureVision Contact Lens
Arm Title
Acuvue Oasys
Arm Type
Active Comparator
Arm Description
Acuvue Oasys Contact Lens
Arm Title
O2Optix
Arm Type
Active Comparator
Arm Description
O2Optix Contact Lens
Intervention Type
Device
Intervention Name(s)
PureVision Contact Lens
Intervention Description
contact lens for daily wear
Intervention Type
Device
Intervention Name(s)
Acuvue Oasys Contact Lens
Intervention Description
contact lens for daily wear
Intervention Type
Device
Intervention Name(s)
O2Optix Contact lens
Intervention Description
contact lens for daily wear
Primary Outcome Measure Information:
Title
Any Slit Lamp Finding > Grade 2
Description
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.
Time Frame
Over all follow-up visits for the 1 month study period
Title
Subjective Responses to Comfort-related Symptoms/Complaints
Description
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.
Time Frame
Over all follow-up visits for 1 month study period
Title
Uncorrected Distance High Contrast Visual Acuity
Description
logMAR high contrast visual acuity (VA) over all visits.
Time Frame
Over all visits for the 1 month study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Cairns, MCOptom, PhD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bruce Anderson, OD
Organizational Affiliation
Anderson & Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anderson & Associates
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparative Performance of PureVision, Acuvue Oasys and O2Optix
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