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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01416142
First received: August 11, 2011
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Myopia
Device: PureVision2 HD contact lenses
Device: Spectacles

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Product Performance of the PureVision®2 HD Contact Lens

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: Screening visit (Visit 1) and one week follow-up(Visit 3) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Preference for Test Lens [ Time Frame: During the movie (Visit 2) ] [ Designated as safety issue: No ]
    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.


Enrollment: 63
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Spectacles
The subject's habitual spectacles (updated or confirmed as correct within the last 2 years)
Device: Spectacles
Spectacles to be worn throughout 1/2 of an HD movie.
Experimental: PureVision2 HD contact lenses
Currently marketed Bausch + Lomb PureVision2 HD contact lenses
Device: 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.

  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416142

Locations
United States, New York
Bausch & Lomb, Inc.
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Bev Barna, CCRA Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01416142     History of Changes
Other Study ID Numbers: 701E
Study First Received: August 11, 2011
Results First Received: February 13, 2013
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014