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OpenTrials
Completed

NCT Number: NCT01416142

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

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch & Lomb, Inc.

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PureVision2 HD contact lenses

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.

Spectacles

Device

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

Primary outcomes

  1. Visual Acuity

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

    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.

Secondary outcomes

  1. Preference for Test Lens

    Time frame: During the movie (Visit 2)

    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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 12, 2011
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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