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Comparative Performance of PureVision, Acuvue Oasys and O2Optix

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00640341
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : March 31, 2011
Last Update Posted : December 12, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myopia Device: PureVision Contact Lens Device: Acuvue Oasys Contact Lens Device: O2Optix Contact lens Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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 Start Date : February 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: PureVision
PureVision Contact Lens
 Device: PureVision Contact Lens
contact lens for daily wear
Active Comparator: Acuvue Oasys
Acuvue Oasys Contact Lens
 Device: Acuvue Oasys Contact Lens
contact lens for daily wear
Active Comparator: O2Optix
O2Optix Contact Lens
 Device: O2Optix Contact lens
contact lens for daily wear


Outcome Measures
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Primary Outcome Measures :
  1. Any Slit Lamp Finding > Grade 2 [ Time Frame: Over all follow-up visits for the 1 month study period ]
    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.

  2. Subjective Responses to Comfort-related Symptoms/Complaints [ Time Frame: Over all follow-up visits for 1 month study period ]
    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.

  3. Uncorrected Distance High Contrast Visual Acuity [ Time Frame: Over all visits for the 1 month study period ]
    logMAR high contrast visual acuity (VA) over all visits.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640341


Locations
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United States, Florida
Anderson & Associates
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Gerard Cairns, MCOptom, PhD Bausch & Lomb Incorporated
Principal Investigator: Bruce Anderson, OD Anderson & Associates
More Information
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00640341    
Other Study ID Numbers: 552
First Posted: March 21, 2008    Key Record Dates
Results First Posted: March 31, 2011
Last Update Posted: December 12, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases