Lens Wear Schedules and End-of-Day Comfort
INVERMERE
Effect of Recovery Periods on Ocular Comfort During Daily Lens Wear
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 12, 2011
CompletedFirst Posted
Study publicly available on registry
September 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
April 30, 2013
CompletedMay 6, 2013
April 1, 2013
7 months
September 12, 2011
March 20, 2013
April 30, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Hour 12
Secondary Outcomes (1)
Mean Non-Invasive Tear Film Break-Up Time (NITBUT)
Hour 12
Study Arms (2)
Lotrafilcon B / Senofilcon A
OTHERLotrafilcon 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 / Lotrafilcon B
OTHERSenofilcon 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
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CIBA VISIONlead
- University of Waterloocollaborator
Study Sites (1)
University of Waterloo Centre for Contact Lens Research
Waterloo, Ontario, N2L 3G1, Canada
Related Publications (1)
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.
PMID: 27362613DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- R. Alan Landers, O.D., M.S., F.A.A.O.
- Organization
- Alcon Research, Ltd.
Study Officials
- PRINCIPAL INVESTIGATOR
Lyndon Jones, PhD FCOptom FAAO, Director
Centre for Contact Lens Research, School of Optometry, University of Waterloo
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2011
First Posted
September 14, 2011
Study Start
August 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
May 6, 2013
Results First Posted
April 30, 2013
Record last verified: 2013-04