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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: PureVision Contact Lens; Device: Acuvue Oasys Contact Lens; Device: O2Optix Contact lens

• Study Type: Interventional
• Enrollment (Actual): 510
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Anderson & Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Gerard Cairns, MCOptom, PhD, Bausch & Lomb Incorporated; Principal Investigator: Bruce Anderson, OD, Anderson & Associates

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: February 20, 2008
• First Submitted That Met QC Criteria: March 20, 2008
• First Posted (Estimate): March 21, 2008

Study Record Updates

• Last Update Posted (Estimate): December 12, 2011
• Last Update Submitted That Met QC Criteria: December 7, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 552