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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01416142
First Posted: August 12, 2011
Last Update Posted: December 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  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
Intervention Model: Crossover Assignment
Masking: None (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) ]
    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) ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01416142     History of Changes
Other Study ID Numbers: 701E
First Submitted: August 11, 2011
First Posted: August 12, 2011
Results First Submitted: February 13, 2013
Results First Posted: December 25, 2013
Last Update Posted: December 25, 2013
Last Verified: November 2013