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OpenTrials
Completed

NCT Number: NCT00661687

Comparative Performance of PureVision Lens Designs

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Laser Focus Sdn Bhd, Vision Correction Centre, Johor Bahru, Malaysia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Currently Marketed PureVision Contact Lens.

Device

Contact lens for continuous wear

Alternate Design of the PureVision Contact Lens.

Device

Contact lens for continuous wear

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 18, 2008
Registry last updated
Dec 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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