One Month Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01300741
First received: February 18, 2011
Last updated: June 26, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Myopia
Device: Lotrafilcon B contact lens (AIR OPTIX® AQUA)
Device: Galyfilcon A contact lens (ACUVUE® ADVANCE® Plus)
Device: Contact lens solution (Clear Care®)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: One Month Performance Comparison Between 2 Commercially Available Silicone Hydrogel Lenses

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Comfort on Insertion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Comfort During the Day [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Comfort at End of Day [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Overall Comfort [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Daytime Vision [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Low Light Vision [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Handling on Insertion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Handling at Removal [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Delivers a Healthy, Natural Feeling [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Lens Awareness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Overall Satisfaction [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Purchase Intent [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 75
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lotrafilcon B
Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW modality).
Device: Lotrafilcon B contact lens (AIR OPTIX® AQUA)
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 Name: AIR OPTIX® AQUA
Device: Contact lens solution (Clear Care®)
Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.
Other Name: Clear Care®
Active Comparator: Galyfilcon A
Galyfilcon A commercially marketed contact lens randomly assigned to one eye, with lotrafilcon B commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW modality).
Device: Galyfilcon A contact lens (ACUVUE® ADVANCE® Plus)
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 Name: ACUVUE® ADVANCE® Plus
Device: Contact lens solution (Clear Care®)
Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.
Other Name: Clear Care®

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ACUVUE ADVANCE Plus contact lenses.
  • Currently sleeping overnight in contact lenses on an occasional or extended wear basis.
  • Other protocol-defined exclusion criteria may apply.
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01300741     History of Changes
Other Study ID Numbers: P-336-C-018
Study First Received: February 18, 2011
Results First Received: April 11, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Contact Lens Solutions
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014