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
  Purpose

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.


Condition Intervention
Myopia
Device: Lotrafilcon B
Device: Senofilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Effect of Recovery Periods on Ocular Comfort During Daily Lens Wear

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 44
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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®
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).
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®

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433549

Locations
Canada, Ontario
University of Waterloo Centre for Contact Lens Research
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
CIBA VISION
University of Waterloo
Investigators
Principal Investigator: Lyndon Jones, PhD FCOptom FAAO, Director Centre for Contact Lens Research, School of Optometry, University of Waterloo
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01433549     History of Changes
Other Study ID Numbers: P-373-C-104
Study First Received: September 12, 2011
Results First Received: March 20, 2013
Last Updated: April 30, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014