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Comparative Performance of PureVision, Acuvue Oasys and O2Optix

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00640341
First received: February 20, 2008
Last updated: December 7, 2011
Last verified: December 2011
History of Changes

February 20, 2008
December 7, 2011
February 2008
April 2008   (final data collection date for primary outcome measure)
  • Any Slit Lamp Finding > Grade 2 [ Time Frame: Over all follow-up visits for the 1 month study period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over all follow-up visits for 1 month study period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over all visits for the 1 month study period ] [ Designated as safety issue: No ]
    logMAR high contrast visual acuity (VA) over all visits.
  • subjective responses to comfort-related symptoms/complaints [ Time Frame: at any visit ] [ Designated as safety issue: No ]
  • slit lamp findings [ Time Frame: at any visit ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00640341 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Myopia
  • Device: PureVision Contact Lens
    contact lens for daily wear
  • Device: Acuvue Oasys Contact Lens
    contact lens for daily wear
  • Device: O2Optix Contact lens
    contact lens for daily wear
  • Experimental: PureVision
    PureVision Contact Lens
    Intervention: Device: PureVision Contact Lens
  • Active Comparator: Acuvue Oasys
    Acuvue Oasys Contact Lens
    Intervention: Device: Acuvue Oasys Contact Lens
  • Active Comparator: O2Optix
    O2Optix Contact Lens
    Intervention: Device: O2Optix Contact lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
510
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00640341
552
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Gerard Cairns, MCOptom, PhD Bausch & Lomb Incorporated
Principal Investigator: Bruce Anderson, OD Anderson & Associates
Bausch & Lomb Incorporated
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP