- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01433549
Lens Wear Schedules and End-of-Day Comfort (INVERMERE)
April 30, 2013 updated by: CIBA VISION
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Waterloo, Ontario, Canada, N2L 3G1
- University of Waterloo Centre for Contact Lens Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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).
|
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
Other Names:
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
Other Names:
|
Other: 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).
|
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
Other Names:
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Hour 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Hour 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lyndon Jones, PhD FCOptom FAAO, Director, Centre for Contact Lens Research, School of Optometry, University of Waterloo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
September 12, 2011
First Submitted That Met QC Criteria
September 12, 2011
First Posted (Estimate)
September 14, 2011
Study Record Updates
Last Update Posted (Estimate)
May 6, 2013
Last Update Submitted That Met QC Criteria
April 30, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-373-C-104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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