Comparative Performance of PureVision Lens Designs

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Myopia

Treatments: Device: Currently Marketed PureVision Contact Lens.; Device: Alternate Design of the PureVision Contact Lens.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00661687

544

Details and patient eligibility

About

The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subject is myopic
• VA correctable to 0.3 logMAR or better (driving vision)
• Clear central cornea

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

206 participants in 2 patient groups

Purevision Contact Lens #1

Active Comparator group

Description:

PureVision Soft Contact Lens Design (currently marketed)

Treatment:

Device: Currently Marketed PureVision Contact Lens.

PureVision Contact Lens #2

Experimental group

Description:

Redesign of the currently marketed PureVision soft contact lens.

Treatment:

Device: Alternate Design of the PureVision Contact Lens.