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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014