Lens Wear Schedules and End-of-Day Comfort (INVERMERE)

This study has been completed.
Sponsor:
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01433549
First received: September 12, 2011
Last updated: April 30, 2013
Last verified: April 2013

September 12, 2011
April 30, 2013
August 2011
March 2012   (final data collection date for primary outcome measure)
Mean End-of-Day Comfort [ Time Frame: Hour 12 ] [ Designated as safety issue: No ]
As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear.
  • Eye Comfort [ Time Frame: After 12 hours (six 2-hour intervals of wear) ] [ Designated as safety issue: No ]
    As assessed by the participant on a questionnaire. For each eye, the participant will draw a mark on a scale that best represents eye comfort.
  • Eye Comfort [ Time Frame: After 12 hours (five 2-hour intervals of wear, each separated by 30 minutes of non-wear) ] [ Designated as safety issue: No ]
    As assessed by the participant on a questionnaire. For each eye, the participant will draw a mark on a scale that best represents eye comfort.
  • Eye Comfort [ Time Frame: After 12 hours (four 2-hour intervals of wear, each separated by 60 minutes of non-wear) ] [ Designated as safety issue: No ]
    As assessed by the participant on a questionnaire. For each eye, the participant will draw a mark on a scale that best represents eye comfort.
  • Eye Comfort [ Time Frame: After 12 hours (four 2-hour intervals of wear, each separated by 80 minutes of non-wear) ] [ Designated as safety issue: No ]
    As assessed by the participant on a questionnaire. For each eye, the participant will draw a mark on a scale that best represents eye comfort.
Complete list of historical versions of study NCT01433549 on ClinicalTrials.gov Archive Site
Mean Non-Invasive Tear Film Break-Up Time (NITBUT) [ Time Frame: Hour 12 ] [ Designated as safety issue: No ]
As assessed by the investigator using a corneal topographer. NITBUT was assessed at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A longer tear film break-up time indicates a more stable tear film and may lead to a more comfortable lens-wearing experience.
  • Non-Invasive Tear Film Break-Up Time [ Time Frame: After 12 hours (six 2-hour intervals of wear) ] [ Designated as safety issue: No ]
    As assessed by the investigator using a corneal topographer. The participant will blink, then keep eyes open while the investigator records the time in seconds for the mires on the topographer image to appear blurry. Three readings per eye will be taken.
  • Non-Invasive Tear Film Break-Up Time [ Time Frame: After 12 hours (five 2-hour intervals of wear, each separated by 30 minutes of non-wear) ] [ Designated as safety issue: No ]
    As assessed by the investigator using a corneal topographer. The participant will blink, then keep eyes open while the investigator records the time in seconds for the mires on the topographer image to appear blurry. Three readings per eye will be taken.
  • Non-Invasive Tear Film Break-Up Time [ Time Frame: After 12 hours (four 2-hour intervals of wear, each separated by 60 minutes of non-wear) ] [ Designated as safety issue: No ]
    As assessed by the investigator using a corneal topographer. The participant will blink, then keep eyes open while the investigator records the time in seconds for the mires on the topographer image to appear blurry. Three readings per eye will be taken.
  • Non-Invasive Tear Film Break-Up Time [ Time Frame: After 12 hours (four 2-hour intervals of wear, each separated by 80 minutes of non-wear) ] [ Designated as safety issue: No ]
    As assessed by the investigator using a corneal topographer. The participant will blink, then keep eyes open while the investigator records the time in seconds for the mires on the topographer image to appear blurry. Three readings per eye will be taken.
Not Provided
Not Provided
 
Lens Wear Schedules and End-of-Day Comfort
Effect of Recovery Periods on Ocular Comfort During Daily Lens Wear

The purpose of this study was to assess the impact of lens-free (recovery) intervals of varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.

This study was conducted in a cross-over design with two phases. Each phase consisted of four cycles approximately 12 hours in length. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A 12-hour lens-free wear period preceded each phase.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Myopia
  • Device: Lotrafilcon B
    Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
    Other Name: AIR OPTIX® AQUA
  • Device: Senofilcon A
    Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
    Other Name: ACUVUE® OASYS®
  • Lotrafilcon B / Senofilcon A
    Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
    Interventions:
    • Device: Lotrafilcon B
    • Device: Senofilcon A
  • Senofilcon A / Lotrafilcon B
    Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
    Interventions:
    • Device: Lotrafilcon B
    • Device: Senofilcon A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is at least 17 years of age and has full legal capacity to volunteer.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Has had an ocular examination in the last two years.
  • Is an adapted soft contact lens wearer.
  • Experiences a decrease in ocular comfort through a lens-wearing day.
  • Has a current pair of spectacles.
  • Has a distance contact lens prescription of +6.00 diopters to -10.00 diopters and an acceptable fit with the study lenses.
  • Has astigmatism less than or equal to -1.00 DC.
  • Achieves visual acuity of 6/9 or better with the study lenses and with habitual spectacles.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Has any ocular disease.
  • Has a systemic condition that may affect a study outcome variable.
  • Is using any systemic or topical medications that may affect ocular health.
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  • Other protocol-defined exclusion criteria may apply.
Both
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01433549
P-373-C-104
No
Alcon Research ( CIBA VISION )
CIBA VISION
University of Waterloo
Principal Investigator: Lyndon Jones, PhD FCOptom FAAO, Director Centre for Contact Lens Research, School of Optometry, University of Waterloo
Alcon Research
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP