Back to resultsEffect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber
Primary Purpose
Myopia, Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
lotrafilcon A contact lenses
comfilcon A contact lenses
Glasses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 70.
- History of end-of-day or low-humidity dryness with contact lenses.
- Healthy eyes.
- Best-corrected visual acuity of 20/50 or better for each eye.
- Usable pair of eye glasses.
- Willing and able to attend required study visits.
- Sign informed consent.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Ocular or systemic allergies or diseases which might interfere with contact lens wear.
- Clinically significant ocular findings which would contraindicate contact lens wear.
- Unable to abstain from artificial tears or other ophthalmic drops for at least 7 days.
- Participation in another clinical study currently or within 30 days of study entry.
- Spectacle astigmatism of >1.00 diopter.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Cetero Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Lotrafilcon A / Comfilcon A / Glasses
comfilcon A / glasses / lotrafilcon A
glasses / lotrafilcon A / comfilcon A
Arm Description
Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Outcomes
Primary Outcome Measures
Tear Osmolarity
The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity.
Ocular Comfort
Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01482312
Brief Title
Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate two different types of contact lenses and their effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lotrafilcon A / Comfilcon A / Glasses
Arm Type
Active Comparator
Arm Description
Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Arm Title
comfilcon A / glasses / lotrafilcon A
Arm Type
Active Comparator
Arm Description
Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Arm Title
glasses / lotrafilcon A / comfilcon A
Arm Type
Active Comparator
Arm Description
Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
Intervention Type
Device
Intervention Name(s)
lotrafilcon A contact lenses
Other Intervention Name(s)
Air Optix Night and Day AQUA
Intervention Description
Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
Intervention Type
Device
Intervention Name(s)
comfilcon A contact lenses
Other Intervention Name(s)
Biofinity
Intervention Description
Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
Intervention Type
Other
Intervention Name(s)
Glasses
Intervention Description
Glasses per habitual prescription
Primary Outcome Measure Information:
Title
Tear Osmolarity
Description
The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity.
Time Frame
90 minutes
Title
Ocular Comfort
Description
Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort.
Time Frame
90 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 to 70.
History of end-of-day or low-humidity dryness with contact lenses.
Healthy eyes.
Best-corrected visual acuity of 20/50 or better for each eye.
Usable pair of eye glasses.
Willing and able to attend required study visits.
Sign informed consent.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Ocular or systemic allergies or diseases which might interfere with contact lens wear.
Clinically significant ocular findings which would contraindicate contact lens wear.
Unable to abstain from artificial tears or other ophthalmic drops for at least 7 days.
Participation in another clinical study currently or within 30 days of study entry.
Spectacle astigmatism of >1.00 diopter.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepen Patel, MD, CCFP
Organizational Affiliation
Cetero Research, San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cetero Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1N2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber
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