Comparative Performance of PureVision, Acuvue Oasys and O2Optix

Phase 4

Completed

• Conditions: Myopia
• Interventions: Device: PureVision Contact Lens; Device: Acuvue Oasys Contact Lens; Device: O2Optix Contact lens

• Registration Number: NCT00640341
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-21
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2011-02-03
• Results First Submitted QC: 2011-03-03
• Results First Posted: 2011-03-31
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 510

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PureVision	PureVision Contact Lens	PureVision Contact Lens
Acuvue Oasys	Acuvue Oasys Contact Lens	Acuvue Oasys Contact Lens
O2Optix	O2Optix Contact lens	O2Optix Contact Lens

Primary Outcome Measures

Name	Time	Method
Any Slit Lamp Finding > Grade 2	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	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	Over all visits for the 1 month study period	logMAR high contrast visual acuity (VA) over all visits.

Trial Locations

Locations (1)

Anderson & Associates; 🇺🇸 Tampa, Florida, United States