Back to resultsDAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
Primary Purpose
Presbyopia, Refractive Error
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nelfilcon A MF contact lenses (DACP MF)
Nelfilcon A single vision contact lenses (DACP)
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring DACP MF, DAILIES AquaComfort Plus® Multifocal, presbyopia, visual performance
Eligibility Criteria
Inclusion Criteria:
- History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week
- Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)
- Requiring lenses within the power range of both study contact lenses to be fitted
- Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1
- Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance
- Acceptable fit with both study contact lenses
- Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
- Current multifocal contact lens wearer
- Current monovision wearer or failed attempt with monovision
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
- Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator
- Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial
- Any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit
- History of herpetic keratitis, ocular surgery or irregular cornea
- Prior refractive surgery (e.g. LASIK, PRK, etc)
- Monocular (only 1 eye with functional vision) or fit with only 1 lens
- Habitually uncorrected anisometropia >2.00D
- Clinically significant anisocoria
- Participation in any clinical trial within 30 days of the enrollment visit
- Other protocol-defined exclusion criteria may apply
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
DACP MF
DACP
DACP MF (Low Add)
Arm Description
DACP MF worn first, followed by DACP and DACP MF (Low Add) as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF will be worn bilaterally (in both eyes).
DACP worn first, followed by DACP MF and DACP MF (Low Add), as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP worn as monovision (distance correction in one eye and near correction in the other eye).
DACP MF (Low Add) worn first, followed by DACP and DACP MF, as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF (Low Add) worn bilaterally (in both eyes).
Outcomes
Primary Outcome Measures
Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance
Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02235831
Brief Title
DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
Official Title
DAILIES® AquaComfort Plus® MF - Comparative Assessment of Visual Performance Using Objective Measurements
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (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 study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.
Detailed Description
In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 5±1 days before switching to the next assigned product.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, Refractive Error
Keywords
DACP MF, DAILIES AquaComfort Plus® Multifocal, presbyopia, visual performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DACP MF
Arm Type
Experimental
Arm Description
DACP MF worn first, followed by DACP and DACP MF (Low Add) as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF will be worn bilaterally (in both eyes).
Arm Title
DACP
Arm Type
Active Comparator
Arm Description
DACP worn first, followed by DACP MF and DACP MF (Low Add), as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP worn as monovision (distance correction in one eye and near correction in the other eye).
Arm Title
DACP MF (Low Add)
Arm Type
Active Comparator
Arm Description
DACP MF (Low Add) worn first, followed by DACP and DACP MF, as randomized. Lenses worn for 5±1 days, 6 hours per day, in a daily wear daily disposable modality. DACP MF (Low Add) worn bilaterally (in both eyes).
Intervention Type
Device
Intervention Name(s)
Nelfilcon A MF contact lenses (DACP MF)
Intervention Description
Multifocal contact lenses in Low, Medium, High Add
Intervention Type
Device
Intervention Name(s)
Nelfilcon A single vision contact lenses (DACP)
Primary Outcome Measure Information:
Title
Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance
Description
Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.
Time Frame
Day 5, each product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week
Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)
Requiring lenses within the power range of both study contact lenses to be fitted
Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1
Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance
Acceptable fit with both study contact lenses
Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible
Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
Current multifocal contact lens wearer
Current monovision wearer or failed attempt with monovision
Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator
Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial
Any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit
History of herpetic keratitis, ocular surgery or irregular cornea
Prior refractive surgery (e.g. LASIK, PRK, etc)
Monocular (only 1 eye with functional vision) or fit with only 1 lens
Habitually uncorrected anisometropia >2.00D
Clinically significant anisocoria
Participation in any clinical trial within 30 days of the enrollment visit
Other protocol-defined exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, EMEA
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
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