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Completed

NCT Number: NCT01433549

Lens Wear Schedules and End-of-Day Comfort

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Waterloo Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

lotrafilcon B

Device

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.

Other names: AIR OPTIX® AQUA

Senofilcon A

Device

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.

Other names: ACUVUE® OASYS®

Primary outcomes

  1. Mean End-of-Day Comfort

    Time frame: Hour 12

    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 outcomes

  1. Mean Non-Invasive Tear Film Break-Up Time (NITBUT)

    Time frame: Hour 12

    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.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Collaborators

  • University of Waterloo

Registry information

Official study title

Effect of Recovery Periods on Ocular Comfort During Daily Lens Wear

Acronym: INVERMERE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 14, 2011
Registry last updated
May 6, 2013

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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