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NCT00640341 Clinical Trial

Comparative Performance of PureVision, Acuvue Oasys and O2Optix

Myopia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00640341
Other study ID # 552
Secondary ID
Status Completed
Phase Phase 4
First received February 20, 2008
Last updated December 7, 2011
Start date February 2008
Est. completion date April 2008

Study information
Verified date December 2011
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 510
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Device:
• PureVision Contact Lens
contact lens for daily wear
• Acuvue Oasys Contact Lens
contact lens for daily wear
• O2Optix Contact lens
contact lens for daily wear

Locations
Country Name City State
United States Anderson & Associates Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary Uncorrected Distance High Contrast Visual Acuity logMAR high contrast visual acuity (VA) over all visits. Over all visits for the 1 month study period No
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