Back to resultsACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delefilcon A contact lenses
Senofilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error
Eligibility Criteria
Inclusion Criteria:
- Must sign informed consent form;
- Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
- Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
- Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
- Cylinder equal or lower than -0.75D in both eyes;
- Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
- Can be successfully fitted with both study lenses at Visit 1;
- Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all 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 1 lens;
- Fitted with monovision;
- Prior refractive surgery;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Pregnant or lactating;
- Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
- Participation in any clinical study within 30 days of Visit 1;
- Current DT1 or AO1D lens wearer;
- Other protocol-specified 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
DT1, then AO1D
AO1D, then DT1
Arm Description
Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.
Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.
Outcomes
Primary Outcome Measures
Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14
Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.
Secondary Outcome Measures
Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14
The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02750813
Brief Title
ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®
Official Title
ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®: Clinical Comparison in a Symptomatic Population
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 27, 2016 (Actual)
Primary Completion Date
August 17, 2016 (Actual)
Study Completion Date
August 17, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon, a Novartis Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DT1, then AO1D
Arm Type
Other
Arm Description
Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.
Arm Title
AO1D, then DT1
Arm Type
Other
Arm Description
Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lenses
Other Intervention Name(s)
DAILIES TOTAL1® (DT1)
Intervention Type
Device
Intervention Name(s)
Senofilcon A contact lenses
Other Intervention Name(s)
ACUVUE® OASYS 1-Day with HydraLuxe™ (AO1D)
Primary Outcome Measure Information:
Title
Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14
Description
Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.
Time Frame
Day 14, each product
Secondary Outcome Measure Information:
Title
Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14
Description
The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.
Time Frame
Day 14, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must sign informed consent form;
Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
Cylinder equal or lower than -0.75D in both eyes;
Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
Can be successfully fitted with both study lenses at Visit 1;
Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all 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 1 lens;
Fitted with monovision;
Prior refractive surgery;
History of herpetic keratitis, ocular surgery, or irregular cornea;
Pregnant or lactating;
Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
Participation in any clinical study within 30 days of Visit 1;
Current DT1 or AO1D lens wearer;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Manager, Global Medical Affairs, GCRA
Organizational Affiliation
Alcon, A Novartis Division
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
ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®
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