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

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

Official Title
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A Study to Evaluate the Product Performance of the PureVision®2 HD Contact Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: PureVision2 HD contact lenses
* Device: Spectacles


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spectacles<br>The subject's habitual spectacles (updated or confirmed as correct within the last 2 years) | Device: Spectacles<br>* Spectacles to be worn throughout 1/2 of an HD movie.<br>|
| Experimental: PureVision2 HD contact lenses<br>Currently marketed Bausch + Lomb PureVision2 HD contact lenses | Device: PureVision2 HD contact lenses<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Screening visit (Visit 1) and one week follow-up(Visit 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the movie (Visit 2) |