Back to resultsClinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delefilcon A contact lenses
Narafilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring DAILIES TOTAL1, contact lenses, myopia
Eligibility Criteria
Inclusion Criteria:
- Sign written Informed Consent Document.
- Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
- Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
- Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
- Willing to wear study lenses for at least eight hours per day and at least five days per week.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Has not worn contact lenses before.
- Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
- Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
- Ocular surgery/trauma within the last six months.
- Topical ocular or systemic use of antibiotics within seven days of enrollment.
- Pregnant or nursing women.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
DAILIES TOTAL1, then TRUEYE
TRUEYE, then DAILIES TOTAL1
Arm Description
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
Outcomes
Primary Outcome Measures
End-of-day Comfort
End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01561560
Brief Title
Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
Official Title
Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
DAILIES TOTAL1, contact lenses, myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DAILIES TOTAL1, then TRUEYE
Arm Type
Other
Arm Description
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
Arm Title
TRUEYE, then DAILIES TOTAL1
Arm Type
Other
Arm Description
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lenses
Other Intervention Name(s)
DAILIES TOTAL1®
Intervention Description
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
Intervention Type
Device
Intervention Name(s)
Narafilcon A contact lenses
Other Intervention Name(s)
1-DAY ACUVUE® TRUEYE™
Intervention Description
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
Primary Outcome Measure Information:
Title
End-of-day Comfort
Description
End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).
Time Frame
Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign written Informed Consent Document.
Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
Willing to wear study lenses for at least eight hours per day and at least five days per week.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Has not worn contact lenses before.
Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
Ocular surgery/trauma within the last six months.
Topical ocular or systemic use of antibiotics within seven days of enrollment.
Pregnant or nursing women.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille Girault
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
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