Comparative Performance of PureVision, Acuvue Oasys and O2Optix

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

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 Intervention Phase
Device: PureVision Contact Lens
Device: Acuvue Oasys Contact Lens
Device: O2Optix Contact lens
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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.

Enrollment: 510
Study Start Date: February 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its identifier: NCT00640341

United States, Florida
Anderson & Associates
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Bausch & Lomb Incorporated
Study Director: Gerard Cairns, MCOptom, PhD Bausch & Lomb Incorporated
Principal Investigator: Bruce Anderson, OD Anderson & Associates
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00640341     History of Changes
Other Study ID Numbers: 552
Study First Received: February 20, 2008
Results First Received: February 3, 2011
Last Updated: December 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases processed this record on April 17, 2014