A Study to Evaluate the Product Performance of the PureVision®2 High Definition (HD) Contact Lens

Bausch + Lomb

Status: Completed

Conditions: Myopia

Treatments: Device: PureVision2 HD contact lenses; Device: Spectacles

Study type: Interventional

Funder types: Industry

Identifiers

NCT01416142

701E

Details and patient eligibility

About

The objective of this study is to evaluate the product performance of PureVision2 HD contact lenses.

Enrollment: 63 patients

Sex: All

Ages: 15 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings
• Subjects must be myopic or hyperopic and require lens correction in each eye
• Subjects must own a pair of spectacles and the spectacle prescription must have been updated or confirmed as correct within the last 2 years.

Exclusion criteria

• Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Any systemic disease affecting ocular health.
• Using any systemic or topical medications that will affect ocular physiology or lens performance.
• Allergic to any component in the Biotrue multi-purpose solution

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Spectacles

Active Comparator group

Description:

The subject's habitual spectacles (updated or confirmed as correct within the last 2 years)

Treatment:

Device: Spectacles

PureVision2 HD contact lenses

Experimental group

Description:

Currently marketed Bausch + Lomb PureVision2 HD contact lenses

Treatment:

Device: PureVision2 HD contact lenses