Skip to main content
OpenTrials
Completed

NCT Number: NCT01300767

Four Week Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

The purpose of this study is to compare the performance of two commercially marketed contact lenses when worn for up to 4 weeks in a daily wear modality.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Habitual spherical soft contact lens wearer who wears a contact lens brand with a recommended replacement schedule of 2 weeks or greater.
  • Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses.
  • Willing and able to wear spherical contact lenses within the available range of powers.
  • Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Eye injury or surgery within twelve weeks prior to enrollment.
  • Currently enrolled in any clinical trial.
  • Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
  • Astigmatism of 1.00D or more.
  • Currently wearing contact lenses in a daily disposable modality.
  • Currently wearing AIR OPTIX AQUA or PureVision 2 contact lenses
  • Currently sleeping overnight in contact lenses on an occasional or extended wear basis.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lotrafilcon B contact lens (AIR OPTIX® AQUA)

Device

Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.

Other names: AIR OPTIX® AQUA

Balafilcon A contact lens (PureVision® 2)

Device

Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.

Other names: PureVision® 2

Contact lens solution (Clear Care®)

Device

Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.

Other names: Clear Care®

Primary outcomes

  1. Comfort on Insertion

    Time frame: 4 weeks

    As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.

  2. Comfort During the Day

    Time frame: 4 weeks

    As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.

  3. Comfort at End of Day

    Time frame: 4 weeks

    As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.

  4. Overall Comfort

    Time frame: 4 weeks

    As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.

  5. Daytime Vision

    Time frame: 4 weeks

    As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.

  6. Low Light Vision

    Time frame: 4 weeks

    As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.

  7. Handling on Insertion

    Time frame: 4 weeks

    As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.

  8. Handling at Removal

    Time frame: 4 weeks

    As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.

  9. Delivers a Healthy, Natural Feeling

    Time frame: 4 weeks

    As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.

  10. Lens Awareness

    Time frame: 4 weeks

    As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.

  11. Overall Satisfaction

    Time frame: 4 weeks

    As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.

  12. Purchase Intent

    Time frame: 4 weeks

    As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, "How likely would you be to purchase these lenses?" Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Official study title

4 Week Performance Comparison Between 2 Commercially Available Silicone Hydrogel Lenses

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 23, 2011
Registry last updated
Jul 10, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.