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

NCT ID: NCT01416142

Last Updated: 2013-12-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spectacles

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

Group Type ACTIVE_COMPARATOR

Spectacles

Intervention Type DEVICE

Spectacles to be worn throughout 1/2 of an HD movie.

PureVision2 HD contact lenses

Currently marketed Bausch + Lomb PureVision2 HD contact lenses

Group Type EXPERIMENTAL

PureVision2 HD contact lenses

Intervention Type DEVICE

Lenses to be worn through 1/2 of an HD movie. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.

Interventions

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PureVision2 HD contact lenses

Lenses to be worn through 1/2 of an HD movie. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.

Intervention Type DEVICE

Spectacles

Spectacles to be worn throughout 1/2 of an HD movie.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bev Barna, CCRA

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Bausch & Lomb, Inc.

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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701E

Identifier Type: -

Identifier Source: org_study_id