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Comparative Performance of PureVision Lens Designs

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ClinicalTrials.gov Identifier: NCT00661687
Recruitment Status : Completed
First Posted : April 18, 2008
Results First Posted : October 15, 2010
Last Update Posted : December 12, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis

Condition or disease Intervention/treatment Phase
Myopia Device: Currently Marketed PureVision Contact Lens. Device: Alternate Design of the PureVision Contact Lens. Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Product Performance of the Redesigned Bausch & Lomb PureVision® Contact Lens (Test) Compared to the Currently Marketed Bausch & Lomb PureVision® Contact Lens (Control) When Worn on an Extended Wear Basis.
Study Start Date : December 2007
Primary Completion Date : February 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Purevision Contact Lens #1
PureVision Soft Contact Lens Design (currently marketed)
Device: Currently Marketed PureVision Contact Lens.
Contact lens for continuous wear
Experimental: PureVision Contact Lens #2
Redesign of the currently marketed PureVision soft contact lens.
Device: Alternate Design of the PureVision Contact Lens.
Contact lens for continuous wear


Outcome Measures

Primary Outcome Measures :
  1. Subjective Responses to Symptoms/Complaints [ Time Frame: Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits ]
    Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.


Secondary Outcome Measures :
  1. LogMAR Visual Acuity [ Time Frame: Mean over all visits - 1 day, 1 week, 1 month ]
    The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.

  2. Lens Characteristics [ Time Frame: Over all scheduled visits day 1 - 1 month ]
    Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subject is myopic
  • VA correctable to 0.3 logMAR or better (driving vision)
  • Clear central cornea

Exclusion Criteria:

  • Systemic disease affecting ocular health
  • using systemic or topical medications
  • wear monovision, multifocal or toric contact lenses
  • Any grade 2 or greater slit lamp findings
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): NCT00661687


Locations
Malaysia
Laser Focus Sdn Bhd, Vision Correction Centre
Johor Bahru, Malaysia, 80400
Philippines
Asian Eye Institute
Makati City, Philippines, 1200
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Gerard Cairns, MCOptom, PhD Bausch & Lomb Incorporated
Principal Investigator: Benny Chian, MCOptom Laser Focus Sdn Bhd, Vision Correction Centre
Principal Investigator: Harvey Siy Uy, MD Asian Eye Institute
More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00661687     History of Changes
Other Study ID Numbers: 544
First Posted: April 18, 2008    Key Record Dates
Results First Posted: October 15, 2010
Last Update Posted: December 12, 2011
Last Verified: December 2011