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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
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

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 ]
    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 ]
    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 ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 processed this record on May 24, 2017