Comparative Performance of PureVision Lens Designs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00661687
First received: April 16, 2008
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Myopia
Device: Currently Marketed PureVision Contact Lens.
Device: Alternate Design of the PureVision Contact Lens.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Subjective Responses to Symptoms/Complaints [ Time Frame: Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits ] [ Designated as safety issue: No ]
    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:
  • LogMAR Visual Acuity [ Time Frame: Mean over all visits - 1 day, 1 week, 1 month ] [ Designated as safety issue: No ]
    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.

  • Lens Characteristics [ Time Frame: Over all scheduled visits day 1 - 1 month ] [ Designated as safety issue: No ]
    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.


Enrollment: 206
Study Start Date: December 2007
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00661687     History of Changes
Other Study ID Numbers: 544
Study First Received: April 16, 2008
Results First Received: February 20, 2009
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 01, 2014