Expired Study
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Tampa, Florida 33612


Purpose:

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.


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


Study is Available At:


Original ID:

552


NCT ID:

NCT00640341


Secondary ID:


Study Acronym:


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.


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bausch & Lomb, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

510


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gerard Cairns, MCOptom, PhD
Study Director
Bausch & Lomb, Inc.

Study Dates

Start Date:February 2008
Completion Date:April 2008
Completion Type:Actual
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:March 2011
Last Changed Date:March 30, 2011
First Received Date:February 20, 2008
First Results Date:February 3, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Uncorrected Distance High Contrast Visual Acuity
Time Frame:Over all visits for the 1 month study period
Safety Issues:False
Description:logMAR high contrast visual acuity (VA) over all visits.
Outcome Type:Primary Outcome
Measure:Subjective Responses to Comfort-related Symptoms/Complaints
Time Frame:Over all follow-up visits for 1 month study period
Safety Issues:False
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.
Outcome Type:Primary Outcome
Measure:Any Slit Lamp Finding > Grade 2
Time Frame:Over all follow-up visits for the 1 month study period
Safety Issues:False
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 neovasculariza

Study Interventions

Intervention Type:Device
Name:PureVision Contact Lens
Description:contact lens for daily wear
Arm Name:PureVision
Intervention Type:Device
Name:Acuvue Oasys Contact Lens
Description:contact lens for daily wear
Arm Name:Acuvue Oasys
Intervention Type:Device
Name:O2Optix Contact lens
Description:contact lens for daily wear
Arm Name:O2Optix

Study Arms

Study Arm Type:Active Comparator
Arm Name:O2Optix
Description:O2Optix Contact Lens
Study Arm Type:Active Comparator
Arm Name:Acuvue Oasys
Description:Acuvue Oasys Contact Lens
Study Arm Type:Experimental
Arm Name:PureVision
Description:PureVision Contact Lens

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bausch & Lomb, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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