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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lotrafilcon B
Senofilcon A
Sponsored by
CIBA VISION
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myopia

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Waterloo Centre for Contact Lens Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Lotrafilcon B / Senofilcon A

Senofilcon A / Lotrafilcon B

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Mean End-of-Day Comfort
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)
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.

Full Information

First Posted
September 12, 2011
Last Updated
April 30, 2013
Sponsor
CIBA VISION
Collaborators
University of Waterloo
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1. Study Identification

Unique Protocol Identification Number
NCT01433549
Brief Title
Lens Wear Schedules and End-of-Day Comfort
Acronym
INVERMERE
Official Title
Effect of Recovery Periods on Ocular Comfort During Daily Lens Wear
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
Collaborators
University of Waterloo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lotrafilcon B / Senofilcon A
Arm Type
Other
Arm Description
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).
Arm Title
Senofilcon A / Lotrafilcon B
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B
Other Intervention Name(s)
AIR OPTIX® AQUA
Intervention Description
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
Intervention Type
Device
Intervention Name(s)
Senofilcon A
Other Intervention Name(s)
ACUVUE® OASYS®
Intervention Description
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
Primary Outcome Measure Information:
Title
Mean End-of-Day Comfort
Description
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.
Time Frame
Hour 12
Secondary Outcome Measure Information:
Title
Mean Non-Invasive Tear Film Break-Up Time (NITBUT)
Description
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.
Time Frame
Hour 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD FCOptom FAAO, Director
Organizational Affiliation
Centre for Contact Lens Research, School of Optometry, University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Waterloo Centre for Contact Lens Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27362613
Citation
Stahl U, Keir NJ, Landers A, Jones LW. Effect of Short Recovery Periods on Ocular Comfort During Daily Lens Wear. Optom Vis Sci. 2016 Aug;93(8):861-71. doi: 10.1097/OPX.0000000000000912.
Results Reference
derived

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Lens Wear Schedules and End-of-Day Comfort

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