Back to resultsDAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Delefilcon A contact lenses
Narafilcon A contact lenses
Somofilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error
Eligibility Criteria
Inclusion Criteria:
- Sign an informed consent document;
- Adapted, current soft contact lens wearer;
- Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
- Can be successfully fitted with study lenses;
- Willing to wear lenses for a minimum of 8 hours prior to each study visit;
- Willing to discontinue artificial tears and rewetting drops usage on the days of study visits;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
- Monocular (only 1 eye with functional vision) or fit with only one lens;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Known pregnancy and lactation;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Sequence 1
Sequence 2
Sequence 3
Sequence 4
Arm Description
Delefilcon A, then narafilcon A, then somofilcon A, then no lens wear. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Narafilcon A, then no lens wear, then delefilcon A, then somofilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Somofilcon A, then delefilcon A, then no lens wear, then narafilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
No lens wear, then somofilcon A, then narafilcon A, then delefilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Outcomes
Primary Outcome Measures
Tear Film Evaporation Rate
Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02517567
Brief Title
DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation
Official Title
Pilot Study on the Effect of Daily Disposable Silicone Hydrogel Contact Lenses on Tear Film Lipids
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 21, 2015 (Actual)
Primary Completion Date
April 22, 2016 (Actual)
Study Completion Date
April 22, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.
Detailed Description
This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Other
Arm Description
Delefilcon A, then narafilcon A, then somofilcon A, then no lens wear. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Arm Title
Sequence 2
Arm Type
Other
Arm Description
Narafilcon A, then no lens wear, then delefilcon A, then somofilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Arm Title
Sequence 3
Arm Type
Other
Arm Description
Somofilcon A, then delefilcon A, then no lens wear, then narafilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Arm Title
Sequence 4
Arm Type
Other
Arm Description
No lens wear, then somofilcon A, then narafilcon A, then delefilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lenses
Other Intervention Name(s)
DAILIES TOTAL1®
Intervention Description
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Intervention Type
Device
Intervention Name(s)
Narafilcon A contact lenses
Other Intervention Name(s)
1-DAY ACUVUE® TruEye®
Intervention Description
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Intervention Type
Device
Intervention Name(s)
Somofilcon A contact lenses
Other Intervention Name(s)
clariti® 1 day
Intervention Description
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Primary Outcome Measure Information:
Title
Tear Film Evaporation Rate
Description
Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
Time Frame
Day 1, Hour 8, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign an informed consent document;
Adapted, current soft contact lens wearer;
Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
Can be successfully fitted with study lenses;
Willing to wear lenses for a minimum of 8 hours prior to each study visit;
Willing to discontinue artificial tears and rewetting drops usage on the days of study visits;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
Monocular (only 1 eye with functional vision) or fit with only one lens;
History of herpetic keratitis, ocular surgery, or irregular cornea;
Known pregnancy and lactation;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, Clinical Trial Management
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation
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