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

N/ACompletedNCT01416142

Bausch & Lomb Incorporated63 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myopia

Interventions

PureVision2 HD contact lensesDEVICE

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.

SpectaclesDEVICE

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

Eligibility

Sex: ALLMin age: 15 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Bausch & Lomb, Inc.

Rochester, New York, United States

Outcomes

Primary Outcomes

Visual Acuity

Visual acuity(VA) measured at the screening visit (all eligible participants) while wearing spectacles and the VA measured at the end of study (Visit 3) 1-Week wearing PureVision2 HD lenses. VA wearing spectacles vs. VA wearing PureVision2 HD Lenses, lower the number the better the VA.

Time frame: Screening visit (Visit 1) and one week follow-up(Visit 3)

Secondary Outcomes

Preference for Test Lens

Proportion of participants preferring the Test lens over their spectacles. Participants changed from Spectacles to PureVision Lenses or PureVision Lenses to spectacles during movie intermission.

Time frame: During the movie (Visit 2)

Data from ClinicalTrials.gov

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